Medtronic Inc.: 109 FDA recall reports
Every medical device recall the FDA has published for Medtronic Inc.. The fault, and how the agency graded it.
109Reports
10Class I
79Ongoing
2026-05-06Most recent
10 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment o
Z-1948-2026 · Class II · reported 2026-05-06 · Ongoing
- Why it was recalled
- Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
- Product
- Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
- Where it went
- Worldwide
- How much
- 120698 units
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090
Z-1098-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
- Product
- Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
- Where it went
- Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam.
- How much
- 442
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD)
Z-0726-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- Product
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 6591 units
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components:
Z-2168-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
- Product
- Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 22091 total devices
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1.
Z-2169-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
- Product
- Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 22091 total devices
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following soft
Z-2127-2025 · Class II · reported 2025-07-23 · Ongoing
- Why it was recalled
- A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
- Product
- Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.
- Where it went
- Worldwide
- How much
- 3909 units
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the followi
Z-2128-2025 · Class II · reported 2025-07-23 · Ongoing
- Why it was recalled
- A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
- Product
- Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.
- Where it went
- Worldwide
- How much
- 5418 units
Azure S DR MRI SureScan, Product number W3DR01
Z-1924-2025 · Class II · reported 2025-06-18 · Ongoing
- Why it was recalled
- Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
- Product
- Azure S DR MRI SureScan, Product number W3DR01
- Where it went
- International distribution of the country of UK. No US distribution.
- How much
- 6
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGR
Z-3152-2024 · Class II · reported 2024-09-25 · Ongoing
- Why it was recalled
- Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
- Product
- 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: ...
- Where it went
- Worldwide distribution.
- How much
- 18788 units
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Z-2197-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 14 units
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Z-2206-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 9
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Z-2190-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 14
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Z-2209-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 5 units
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Z-2210-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 8 units
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Z-2205-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 13 units
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Z-2207-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 36 units
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Z-2211-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 9 units
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Z-2202-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 26 units
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Z-2208-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 4 units
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Z-2200-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 2 units
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Z-2204-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 6 units
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
Z-2191-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 8 units
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Z-2196-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 1 unit
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model
Z-2212-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD CRT-D SureScan, Model Number DTMC2QQ. i. EVERA MRI XT DR SureScan, Model Number DDMB2D4. j. VISIA AF MRI XT VR SureScan, Model Number DVFB2D1. k. VISIA AF MRI S VR SureScan, Model Number DVFC3D4. l. VISIA AF MRI XT VR SureScan, Model Number DVFB2D4.
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 82 units
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Z-2194-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 58 units
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Z-2195-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 26 units
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Z-2192-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 14 units
EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Z-2199-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 40 units
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
Z-2203-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 46 units
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Z-2193-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Product
- COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- How much
- 11 units
Showing the 30 most recent of 109. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls