Class II — Medtronic Perfusion Systems
| Recalling firm | Medtronic Perfusion Systems |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722 |
| Quantity | 3,110 units |
| Distribution | Worldwide - US Nationwide distribution. |
| Initiated | 2026-06-24 |
| Classified | 2026-07-27 |
| Recall number | Z-2809-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic Perfusion Systems (Z-2809-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99320/
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