Arterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
Medtronic is recalling 3,621 EOPA 3D Arterial Cannula DIL TIP 22FR units because pinhole leaks may occur during cardiopulmonary bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm medical device with no reported injuries stated in the source. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Medtronic Perfusion Systems is recalling 3,621 units of the EOPA 3D Arterial Cannula DIL TIP 22FR (Model 78222), an arterial return cannula used during cardiopulmonary bypass. The recall covers worldwide distribution, including nationwide U.S. distribution.
The recall was issued because pinhole leaks may occur in the wire-wound body of the cannula during cardiopulmonary bypass. Potential risks associated with this condition include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Patients undergoing cardiopulmonary bypass with an affected cannula could be at risk. The affected lot numbers are listed in the recall notice; users should verify whether their device is included.
The FDA has classified this as a Class II recall. The notice does not include specific consumer instructions, so healthcare providers and patients should contact Medtronic Perfusion Systems for guidance.
The recalled product
- Product
- EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- pinhole-leak
- hypovolemia
- vessel-laceration
- ischemia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 20763000135700
- UDI-DI: 00763000135706
- Lot Numbers: 0232612916 0232709001
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
FDA (Devices) · 2026-08-05
- ModerateAMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05