Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–23 of 23 recalls
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…
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.
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation.…
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
The catheters may not retain their shape.
The catheters may not retain their shape.
The catheters may not retain their shape.
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.…
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.