Medtronic Perfusion Systems

13 FDA enforcement actions

13 Total Recalls

4 Class I

9 Class II

0 Class III

Firm Details

Product Types: device
States: MN

All Recalls

Class II: Risk 10/20/2025 device

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.
Class II: Risk 10/03/2025 device

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.
Class II: Risk 09/12/2025 device

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Class I: Dangerous 08/06/2025 device

The catheters may not retain their shape.
Class I: Dangerous 08/06/2025 device

The catheters may not retain their shape.
Class I: Dangerous 08/06/2025 device

The catheters may not retain their shape.
Class I: Dangerous 02/05/2025 device

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).
Class II: Risk 12/12/2024 device

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II: Risk 12/12/2024 device

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II: Risk 12/12/2024 device

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II: Risk 10/03/2024 device

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Class II: Risk 07/09/2024 device

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).
Class II: Risk 05/16/2024 device

Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.