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Medtronic Neuromodulation
Medtronic Neuromodulation: 98 FDA recall reports
Every medical device recall the FDA has published for Medtronic Neuromodulation. The fault, and how the agency graded it.
98Reports
14Class I
52Ongoing
2026-06-03Most recent
14 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 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, f
Z-2240-2026 · Class II · reported 2026-06-03 · Ongoing
- Why it was recalled
- A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
- Product
- Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
- Where it went
- Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
- How much
- 275 units
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, f
Z-2241-2026 · Class II · reported 2026-06-03 · Ongoing
- Why it was recalled
- A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
- Product
- Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
- Where it went
- Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
- How much
- 31 units
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the follow
Z-2201-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
- Product
- Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump
- Where it went
- Worldwide distribution.
- How much
- 10165 units
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200.
Z-1043-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
- Product
- A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 7123
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A
Z-0996-2026 · Class II · reported 2025-12-31 · Ongoing
- Why it was recalled
- Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
- Product
- Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG
- Where it went
- Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Reunion, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.
- How much
- 7667 devices
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Z-1704-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
- Product
- Enhanced Verify Evaluation Handset (CFN HH90130FA)
- Where it went
- US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI.
- How much
- 534
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and
Z-1543-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
- Product
- Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
- Where it went
- Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Puerto Rico, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- How much
- 1493 devices
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Z-1506-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
- Product
- A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.
- How much
- 4365 units
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLE
Z-0773-2025 · Class II · reported 2025-01-08 · Ongoing
- Why it was recalled
- Software issues were identified in application version 2.x.
- Product
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 566 systems
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLE
Z-0772-2025 · Class II · reported 2025-01-08 · Ongoing
- Why it was recalled
- Software issues were identified in application version 2.x.
- Product
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 59 systems
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLE
Z-0771-2025 · Class II · reported 2025-01-08 · Ongoing
- Why it was recalled
- Software issues were identified in application version 2.x.
- Product
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 319 systems
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLE
Z-0774-2025 · Class II · reported 2025-01-08 · Ongoing
- Why it was recalled
- Software issues were identified in application version 2.x.
- Product
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 3981 systems
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for
Z-0372-2025 · Class II · reported 2024-11-20 · Ongoing
- Why it was recalled
- The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
- Product
- Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
- How much
- 118 wireless rechargers
SynchroMed II Infusion Pump. Product Number: 8637-20
Z-0137-2025 · Class II · reported 2024-10-30 · Ongoing
- Why it was recalled
- Potential for error and inability to interrogate pump due to data corruption in the pump memory.
- Product
- SynchroMed II Infusion Pump. Product Number: 8637-20
- Where it went
- US Nationwide distribution in the state of Mississippi.
- How much
- 1 unit
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Z-0206-2025 · Class II · reported 2024-10-30 · Ongoing
- Why it was recalled
- A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
- Product
- Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
- Where it went
- International distribution to the countries of Germany, UK, and Israel.
- How much
- 39 units
Vanta Implantable Neurostimulator (INS), Model 977006
Z-0132-2025 · Class II · reported 2024-10-23 · Ongoing
- Why it was recalled
- Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
- Product
- Vanta Implantable Neurostimulator (INS), Model 977006
- Where it went
- Worldwide distribution.
- How much
- 11789 units
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, contain
Z-3073-2024 · Class II · reported 2024-09-18 · Ongoing
- Why it was recalled
- A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
- Product
- Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
- Where it went
- US Nationwide distribution.
- How much
- 211 devices
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584
Z-2427-2024 · Class II · reported 2024-07-31 · Ongoing
- Why it was recalled
- Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
- Product
- A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1
- Where it went
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, Viet Nam.
- How much
- 18,010 units
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter p
Z-2352-2024 · Class II · reported 2024-07-24 · Ongoing
- Why it was recalled
- Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
- Product
- Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
- Where it went
- Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Cyprus, Czech Rep, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Guadeloupe, Germany, Greece, Hong Kong, Hungary, Indonesia, Italy, Iran, Islamic Republic, Iraq, Ireland, Jordan, Kazakhstan, Korean Republic of, Kuwait, Latvia, Lebanon, Lithuania, Libya, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherland, New Zealand, Norway, Oman, Panama, Pakistan, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirate, and United Kingdom.
- How much
- 111762 units
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Z-1691-2024 · Class II · reported 2024-05-08 · Ongoing
- Why it was recalled
- inability to reprogram one device
- Product
- Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
- Where it went
- International distribution in the country of UK.
- How much
- 1 unit
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Z-0780-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
- Product
- Model A710 Intellis Clinician Programmer Application, version 2.0.97
- Where it went
- Germany
- How much
- 1 tablet
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Z-0614-2024 · Class II · reported 2024-01-03 · Ongoing
- Why it was recalled
- Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.
- Product
- Medtronic SynchroMed II, Model 8637-20, Programmable pump
- Where it went
- Worldwide
- How much
- 98311 units
Medtronic SynchroMed II, Model 8637-40, Programmable pump
Z-0615-2024 · Class II · reported 2024-01-03 · Ongoing
- Why it was recalled
- Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.
- Product
- Medtronic SynchroMed II, Model 8637-40, Programmable pump
- Where it went
- Worldwide
- How much
- 78532 units
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Z-0354-2024 · Class II · reported 2023-11-29 · Ongoing
- Why it was recalled
- Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
- Product
- Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
- Where it went
- International distribution to the countries of S. Korea and Turkey.
- How much
- 26 units
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Z-0217-2024 · Class II · reported 2023-11-08 · Completed
- Why it was recalled
- There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
- Product
- LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Where it went
- US: MO, FL, TX, WA
- How much
- 14 units
SenSight Connector Plug, Model Number B31061.
Z-0121-2024 · Class II · reported 2023-10-25 · Ongoing
- Why it was recalled
- Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.
- Product
- SenSight Connector Plug, Model Number B31061.
- Where it went
- US Nationwide Distribution
- How much
- 65 devices
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulator
Z-2657-2023 · Class II · reported 2023-10-11 · Terminated
- Why it was recalled
- The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.
- Product
- Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
- Where it went
- Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
- How much
- 2,408 devices
Medtronic InterStim Ground Pad REF 041826
Z-2365-2023 · Class II · reported 2023-08-16 · Ongoing
- Why it was recalled
- Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
- Product
- Medtronic InterStim Ground Pad REF 041826
- Where it went
- International distribution to the country of Iran.
- How much
- 360 packs (36 kits of 10 packs each)
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Z-2226-2023 · Class II · reported 2023-08-02 · Ongoing
- Why it was recalled
- When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
- Product
- A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
- Where it went
- International distribution to the countries of Israel and Serbia.
- How much
- 2 clinician tablets
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Z-2036-2023 · Class II · reported 2023-07-05 · Ongoing
- Why it was recalled
- A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.
- Product
- Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
- Where it went
- Worldwide distribution.
- How much
- 3791 devices
Showing the 30 most recent of 98. 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.
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