Medtronic Perfusion Systems: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Recall Summary Medtronic is recalling specific arterial cannulae (tubes used during heart-lung bypass surgery) because they may develop small leaks in their wire-reinforced sections. The affected products are the 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae (Model 77722), which have been distributed nationwide across the United States. This recall affects medical facilities that use these devices for cardiopulmonary bypass procedures.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
- 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/ce4768d8-5ddd-4398-9dc8-b1b2d4487fc8