The FDA has posted 23 enforcement recalls from Medtronic Perfusion Systems since 2025, including 4 Class I (most serious) recalls. Most recent report: Jul 1, 2026.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.…
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.…
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.…
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.
Firm name as filed with the FDA: “Medtronic Perfusion Systems”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.