Medtronic Perfusion Systems: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Numb
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medtronic Perfusion Systems
- Product
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution.
- Recall initiated
- 2026-06-24
- Code info
- UDI-DI: 20763000135632, Lot Numbers: 0232446429 0232446444 0232486752 0232601515 0232601516 0232601522 0232601586 0232601591 0232601593 0232602180 0232798265 0232798353 0232849583 0232894981 0232895082 0232902694 0232902697 0232902698 0232902700 0232902803 0232902805 0232902846 0232985469 0233009922 0233108251 0233116991 0233127352 0233334923 0233334966 0233426694 0233426695 0233528727; UDI-DI: 00763000135638, Lot Numbers: 0232446444 0232798353 0232895082 0232902697 0232902803 0232902846 0232985469 0233127352 0233334923
- Product quantity
- 21,290 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Brooklyn Park
- State
- MN
- Country
- United States
- Event id
- 99320
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