EOPA 3D Arterial Cannula 22FR — Class II medical device recall Z-2811-2026
Ongoing recall by Medtronic Perfusion Systems, reported 2026-08-05, distributed nationwide. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with
| Recall number | Z-2811-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2026-06-24 |
| Classified | 2026-07-27 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,424 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00199150023257, 20199150023251 |
| Lot numbers | 0232709184, 0232745036, 0232798416, 0232862784, 0232862787 |
| Model numbers | 78322 |
Product
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2811-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.