FDA Device recall Z-2083-2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description:…
- FDA Device
- Class I
- ongoing
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class I recall of Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description:… by Edwards Lifesciences, citing due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2083-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-14 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
Reason
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Identifiers
| code_info | Lot Code: Model No; FEMII016AS; UDI: 0060913168341; All lots up to: BSLC1689 Serial Numbers: FEMII016AS FEMII016AS FEMII016AS |
|---|
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-2083-2025%22
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