The FDA has posted 20 enforcement recalls of cardiopulmonary bypass vascular cannula and tubing catheter devices since 2025, none of them Class I (most serious). Most recent report: Sep 23, 2026.
The packaging may not consistently maintain sterile barrier integrity.
The packaging may not consistently maintain sterile barrier integrity.
The packaging may not consistently maintain sterile barrier integrity.
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.
Certain lots of product have the potential for a sterile barrier breach.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass”). Informational only — verify against the FDA before acting.