Medtronic Perfusion Systems — EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 24, 2026
Worldwide - US Nationwide distribution.
What's affected?
- Product
- EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
- Lot code
- 0232602300
Additional details
UDI-DI: 20763000135700, Lot Numbers: 0232602300 0232602383 0232612916 0232680078 0232708967 0232709001 0232910880 0232910881 0232910882 0233077983 0233245850 0233245860 0233245980; UDI-DI: 00763000135706, Lot Numbers: 0232612916 0232709001
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,621 units.
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