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Medtronic Perfusion Systems
Medtronic Perfusion Systems: 110 FDA recall reports
Every medical device recall the FDA has published for Medtronic Perfusion Systems. The fault, and how the agency graded it.
110Reports
15Class I
57Ongoing
2026-07-22Most recent
15 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 Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Z-2739-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- Product
- Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
- Where it went
- Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular
Z-2738-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- Product
- Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
- Where it went
- Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Z-2576-2026 · Class II · reported 2026-07-01 · Ongoing
- Why it was recalled
- During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- Product
- Octopus Evolution AS Tissue Stabilizer, Model TS2500
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 288 units
Octopus 4 Tissue Stabilizer, Model 29400
Z-2577-2026 · Class II · reported 2026-07-01 · Ongoing
- Why it was recalled
- During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- Product
- Octopus 4 Tissue Stabilizer, Model 29400
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 590 units
Octopus Evolution Tissue Stabilizer, Model TS2000
Z-2575-2026 · Class II · reported 2026-07-01 · Ongoing
- Why it was recalled
- During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- Product
- Octopus Evolution Tissue Stabilizer, Model TS2000
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 134 units
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass va
Z-2218-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Certain lots of product have the potential for a sterile barrier breach.
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- How much
- 2620 units
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass va
Z-2219-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Certain lots of product have the potential for a sterile barrier breach.
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- How much
- 3210 units
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass v
Z-2216-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Certain lots of product have the potential for a sterile barrier breach.
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- How much
- 600 units
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypas
Z-2214-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Certain lots of product have the potential for a sterile barrier breach.
- Product
- Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- How much
- 3790 units
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass va
Z-2217-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Certain lots of product have the potential for a sterile barrier breach.
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- How much
- 840 units
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass va
Z-2221-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Certain lots of product have the potential for a sterile barrier breach.
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- How much
- 280 units
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass va
Z-2222-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Certain lots of product have the potential for a sterile barrier breach.
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- How much
- 260 units
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass v
Z-2220-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Certain lots of product have the potential for a sterile barrier breach.
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- How much
- 481 units
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass
Z-2215-2026 · Class II · reported 2026-05-27 · Ongoing
- Why it was recalled
- Certain lots of product have the potential for a sterile barrier breach.
- Product
- Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
- How much
- 6572 units
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Z-1473-2026 · Class II · reported 2026-03-04 · Ongoing
- Why it was recalled
- During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- Product
- Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
- Where it went
- US Nationwide. Global Distribution.
- How much
- 939 units
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Z-0539-2026 · Class II · reported 2025-11-26 · Ongoing
- Why it was recalled
- Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
- Product
- Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
- Where it went
- US Nationwide distribution in the states of Hawaii and New York.
- How much
- 3850 units
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Z-0509-2026 · Class II · reported 2025-11-26 · Ongoing
- Why it was recalled
- As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.
- Product
- MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
- Where it went
- US Nationwide distribution.
- How much
- 167 units
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product N
Z-0487-2026 · Class II · reported 2025-11-19 · Ongoing
- Why it was recalled
- Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
- Product
- Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
- Where it went
- US States: AZ, CA, TN
- How much
- 26 units
Class I
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 121
Z-2481-2025 · Class I · reported 2025-09-10 · Ongoing
- Why it was recalled
- The catheters may not retain their shape.
- Product
- DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 41200 units
Class I
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 121
Z-2482-2025 · Class I · reported 2025-09-10 · Ongoing
- Why it was recalled
- The catheters may not retain their shape.
- Product
- DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 25261 units
Class I
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 121
Z-2480-2025 · Class I · reported 2025-09-10 · Ongoing
- Why it was recalled
- The catheters may not retain their shape.
- Product
- DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 34549 units
Class I
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANN
Z-1306-2025 · Class I · reported 2025-03-19 · Ongoing
- Why it was recalled
- Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
- Product
- Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014
- Where it went
- Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Canada Canary Islands Cayman Islands Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Georgia Germany Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Moldova, Republic Of Montenegro Morocco Namibia Nepal Netherlands New Zealand North Macedonia NorthernIreland Norway Oman Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Qatar Reunion Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Suriname Sweden Switzerland Taiwan Thailand Turkey Ukraine United Arab Emirates United Kingdom Viet Nam Yemen
- How much
- 316,205
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Z-0984-2025 · Class II · reported 2025-01-29 · Ongoing
- Why it was recalled
- Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- Product
- DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 745 units
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Z-0985-2025 · Class II · reported 2025-01-29 · Ongoing
- Why it was recalled
- Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- Product
- EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 930 units
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Z-0986-2025 · Class II · reported 2025-01-29 · Ongoing
- Why it was recalled
- Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- Product
- Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 440 units
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Z-0289-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
- Product
- Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
- Where it went
- US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
- How much
- 420 units
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Z-3128-2024 · Class II · reported 2024-09-18 · Ongoing
- Why it was recalled
- During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
- Product
- Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
- Where it went
- Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.
- How much
- 290 units
TourniKwik Tourniquet Set (CFN 79012)
Z-2423-2024 · Class II · reported 2024-07-31 · Ongoing
- Why it was recalled
- Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
- Product
- TourniKwik Tourniquet Set (CFN 79012)
- Where it went
- Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
- How much
- 636 units
Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 c
Z-1802-2024 · Class II · reported 2024-05-22 · Ongoing
- Why it was recalled
- Potential for unsealed sterile packing.
- Product
- Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
- Where it went
- Worldwide distribution.
- How much
- 1624 units
Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vesse
Z-1799-2024 · Class II · reported 2024-05-22 · Ongoing
- Why it was recalled
- Potential for unsealed sterile packing.
- Product
- Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003
- Where it went
- Worldwide distribution.
- How much
- 5719 units
Showing the 30 most recent of 110. 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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