FDAHealthJune 24, 2026
Medtronic Perfusion Systems — EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
⚠️ 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 Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
- Lot code
- 0232657469
Additional details
UDI-DI: 20199150023312, Lot Numbers: 0232657469 0232670800 0232744945 0232798410 0232862769 0232985251 0233116924 0233116931; UDI-DI: 00199150023318, Lot Numbers: 0232744945
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,110 units.
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