Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8 — Class II medical device recall Z-1371-2015
Terminated recall by Edwards Lifesciences, LLC, reported 2015-04-08, distributed nationwide. Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French becaus
| Recall number | Z-1371-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2015-03-23 |
| Classified | 2015-04-02 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2017-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 5,125 units |
| Lot numbers | 59747819, 59773806, 59775775, 59775776, 59775777, 59792415, 59792416, 59796683, 59801792, 59807986, 59849119, 59849124, 59852930, 59852934, 59852935, 59867050, 59867051, 59867064, 59873251, 59873252, 59873263, 59884766, 59884778, 59890916, 59890924, 59896910, FEMII008A/59751073, FEMII008AT/59807985, FEMII008V/59873250, FEMII010A/59740468, FEMII010AT, FEMII010V/59751074, FEMII012A, FEMII012AT/59852940, FEMII012V/59723307 |
| Model numbers | FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, FEMII012V |
Product
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.
Reason for recall
Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula.
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.