FDA Device recall Z-2807-2026
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Num…
- FDA Device
- Class II
- ongoing
- Published 2026-08-05
On 2026-08-05 the FDA classified a Class II recall of EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Num… by Medtronic Perfusion Systems, citing pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2807-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-24 |
| Published | 2026-08-05 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
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.
Identifiers
| code_info | UDI-DI: 00199150023288, Lot Numbers: 0233286436; UDI-DI: 20199150023282, Lot Numbers: 0232709428 0232744924 0232745061…UDI-DI: 00199150023288, Lot Numbers: 0233286436; UDI-DI: 20199150023282, Lot Numbers: 0232709428 0232744924 0232745061 0232745092 0232798556 0232862763 0232862778 0232862794 0232862798 0232903216 0232903291 0232903383 0232990983 0233286318 0233286414 0233286436 0233427120 0233528730 0233553623 0233556386 0233585113 0233585114 0232670802 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2807-2026%22
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