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

FDA product code DWF · Class 2 · Cardiovascular

8,312
Registered devices
6,232
Adverse events
560
Recalls
401
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-24Medtronic Perfusion SystemsMedtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
2026-06-24Medtronic Perfusion SystemsMedtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
2026-06-24Medtronic Perfusion SystemsMedtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
2026-06-24Medtronic Perfusion SystemsMedtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
2026-06-24Medtronic Perfusion SystemsMedtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
2026-06-24Medtronic Perfusion SystemsMedtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
2026-05-25Medtronic Perfusion SystemsMedtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
2026-05-25Medtronic Perfusion SystemsMedtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
2026-04-21Medtronic Perfusion SystemsCertain lots of product have the potential for a sterile barrier breach.
2026-04-21Medtronic Perfusion SystemsCertain lots of product have the potential for a sterile barrier breach.

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