Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula… — Class I medical device recall Z-2084-2025
Ongoing recall by Edwards Lifesciences, LLC, reported 2025-07-16, distributed nationwide. due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body
| Recall number | Z-2084-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2025-05-14 |
| Classified | 2025-07-10 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CO, CY, CZ, DE, DK, ES, FR, GB, GR, HU, IE, IL, IN, IS, IT, JP, KR, LU, MT, MX, MY, NL, NO, PA, PK, PL, PT, RO, SE, SG, SK, TH, TW, ZA |
| Quantity | 13,240 |
| Lot numbers | BSLC9148 |
| Serial numbers | 130468, 130599, 130704, 130848, 130953, 131048, 131286, 131430, 131626, 131774, 131775, 132004, 132005, 132510, BSLC0025, BSLC0121, BSLC0422, BSLC1115, BSLC1470, BSLC4161, BSLC4472, BSLC5041, BSLC5293, BSLC5842, BSLC6163 and 5 more |
| Model numbers | FEMII018A |
Product
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A 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 for recall
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Machine access
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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.