The FDA has posted 31 enforcement recalls from Medtronic Perfusion Systems since 2025, including 4 Class I (most serious) recalls. Most recent report: Aug 5, 2026.
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 dys…
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 dys…
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 dys…
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 dys…
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 dys…
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 dys…
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.…
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.
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.