Medtronic Perfusion Systems recalls
21 official recalls and safety alerts involving Medtronic Perfusion Systems since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Medtronic Perfusion Systems or the relevant agency.
- 2026-08-05
USMedtronic Perfusion Systems recalls EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula,…
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ…
- 2026-07-22
- US
Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
FDA · DeviceMedtronic Perfusion SystemsWorldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA,…Official notice → - 2026-07-01
- US
Medtronic Perfusion Systems recalls Octopus Evolution AS Tissue Stabilizer, Model TS2500
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…
- 2026-05-27
- US
Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2026-03-04
- US
Medtronic Perfusion Systems recalls Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
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…
- 2025-11-26
- US
Medtronic Perfusion Systems recalls Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
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.
FDA · DeviceMedtronic Perfusion SystemsUS Nationwide distribution in the states of Hawaii and New York.Official notice → - US
Medtronic Perfusion Systems recalls MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
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…
- 2025-11-19
- US
Medtronic Perfusion Systems recalls Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
- 2025-09-10
- US
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
The catheters may not retain their shape.
- 2025-03-19
- US
Medtronic Perfusion Systems recalls Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD…
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…
FDA · DeviceMedtronic Perfusion SystemsDomestic distribution nationwide. International distribution to the following…Official notice → - 2025-01-29
- US
Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- 2024-11-13
- US
Medtronic Perfusion Systems recalls Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
FDA · DeviceMedtronic Perfusion SystemsUS: NY, OH, IL, NJ, MI, TN, WI, Australia, and SingaporeOfficial notice → - 2024-09-18
- US
Medtronic Perfusion Systems recalls Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
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).
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide and the countries of Cambodia, Greece,…Official notice → - 2024-07-31
- US
Medtronic Perfusion Systems recalls TourniKwik Tourniquet Set (CFN 79012)
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
FDA · DeviceMedtronic Perfusion SystemsWorldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and…Official notice → - 2024-05-22
- US
- 2024-03-27
- US
Medtronic Perfusion Systems recalls Medtronic DLP Vessel Cannula, Model Number REF 30000
Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
FDA · DeviceMedtronic Perfusion SystemsUS and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy,…Official notice → - 2023-02-08
- US
Medtronic Perfusion Systems recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or…
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia,…Official notice → - 2022-06-01
- US
Medtronic Perfusion Systems recalls Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the…
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide distribution in the states of CA, ND,…Official notice → - 2022-01-19
- US
Medtronic Perfusion Systems recalls Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R…
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2021-12-01
- US
Medtronic Perfusion Systems recalls Cardioblate CryoFlex Surgical Ablation Console
There is potential for intermittent electrical connectivity between the console and probe.
FDA · DeviceMedtronic Perfusion SystemsDistribution in US - IL, KS, and UT Distribution outside of US to Australia…Official notice → - 2021-10-13
- US
Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion…
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide distribution in the state of…Official notice →