The FDA has posted 16 enforcement recalls of cardiopulmonary bypass vascular cannula and tubing catheter devices since 2025, including 4 Class I (most serious) recalls. Most recent report: May 27, 2026.
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.
The catheters may not retain their shape.
The catheters may not retain their shape.
The catheters may not retain their shape.
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.