Medtronic Perfusion Systems: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Recall Summary Medtronic is recalling certain arterial cannulae (tubes used during heart bypass surgery) because they may develop small leaks in their wire-reinforced body during use. The affected products include the EOPA 3D Arterial Cannula model 78222 and related EOPA models, distributed nationwide and internationally. This recall affects medical facilities that use these devices for cardiopulmonary bypass procedures.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/22ccfd28-40fe-4d48-8f1f-b5801cf94574