Medtronic Perfusion Systems: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic is recalling certain arterial cannulae (tubes used to deliver blood during heart bypass surgery) because pinhole leaks have been found in the wire-wound body of the devices. The affected products are the EOPA 3D Arterial Cannula 22FR and EOPA Elongated One-Piece Arterial Cannulae, distributed nationwide across all U.S. states. This is a Class II recall, meaning the devices could cause serious health problems but are unlikely to cause death.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
- 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/edbc8e36-fbff-457d-a798-8b6a51da2064