Overview of recall records associated with Medtronic Perfusion Systems, including dates, categories and classifications where available.
Classification mix: Class II: 72, Class I: 12.
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,…
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,…
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,…
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,…
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,…
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,…
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
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,…
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,…
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,…
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
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…
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. When this occurs, the touch screen may become…
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…
This page summarizes recall records in which the official source identifies Medtronic Perfusion Systems as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
