EOPA 3D Arterial Cannula 22FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIOngoing
Summary: Medtronic Perfusion Systems is recalling EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322. Reason: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
What is being recalled
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Why
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution.
How to tell if yours is affected
UDI-DI: 20199150023251, Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787; UDI-DI: 00199150023257, Lot Numbers: 0232862787
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2811-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 24, 2026 |
| Reported | August 5, 2026 |
| Company | Medtronic Perfusion Systems |
| Company location | Brooklyn Park, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,424 units |
More recalls from Medtronic Perfusion Systems · all medical device recalls · recalls from June 2026