FDA Device recall Z-2806-2026
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-2806-2026 |
| 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 77422
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: 20763000135632, Lot Numbers: 0232446429 0232446444 0232486752 0232601515 0232601516 0232601522 0232601586 02326…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 |
|---|
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-2806-2026%22
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