FDA Device Intelligence
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Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

FDA product code DWF · Class 2 · Cardiovascular

8,434
Registered devices
6,391
Adverse events
563
Recalls
403
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-07-31Maquet Cardiopulmonary GmbhThe packaging may not consistently maintain sterile barrier integrity.
2026-07-31Maquet Cardiopulmonary GmbhThe packaging may not consistently maintain sterile barrier integrity.
2026-07-31Maquet Cardiopulmonary GmbhThe packaging may not consistently maintain sterile barrier integrity.
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel lac
2026-05-25Medtronic Perfusion SystemsMedtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.