Recall Z-2810-2026
- Recall number
- Z-2810-2026
- Event number
- 99320
- Firm
- Medtronic Perfusion Systems
- Firm FEI
- 1000116158
- Product code
- DWF
- Status
- Open, Classified
- Initiated
- 2026-06-24
- Posted
- 2026-07-27
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K260195, K033463, K845046, K833047, K905224, K971019, K993677, K964205, K840001, K810820, K791832, K901231, K874899, K861096, K861116, K910021, K994243, K870507, K890980, K822317, K925442, K801401, K001371, K781990, K140165, K770068, K872762, K022022, K120988, K150422
Product#
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
Reason for Recall#
Medtronic 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 cardiopulmonary bypass procedures.