FDA Device recall Z-0985-2025
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) by Medtronic Perfusion Systems, citing incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0985-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-12 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Reason
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Identifiers
| code_info | Model 77418 UDI-DI: 20763000135618, Lot Numbers: 2022041038; Model 77422 UDI-DI: 20643169485970, Lot Number: 2023020934 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0985-2025%22
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