CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report
Fem-Flex II Femoral Arterial Cannula 8, 10,Sterile EO recalled
Edwards Lifesciences is recalling Fem-Flex II Femoral Arterial Cannula 8, 10,Sterile EO, distributed nationwide in the US. The recall was initiated on 23 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1371-2015
- FDA event ID
- 70820
- Recalling firm
- Edwards Lifesciences, Draper, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Mar 2015
- FDA classified
- 2 Apr 2015
- Reported
- 8 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 23 Mar 2015 | Recall initiated by company | |
| 2 Apr 2015 | Classified by FDA | +10 days |
| 8 Apr 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model/Lot Numbers: FEMII008A/59751073, 59775775, 59775776, 59775777 & 59852930; FEMII008AT/59807985, 59867050, & 59873263; FEMII008V/59873250 & 59873251; FEMII010A/59740468, 59773806, 59792415, 59792416 & 59852934; FEMII010AT/ 59747819, 59807986,59852935, 59890916 & 59896910; FEMII010V/59751074, 59849119 & 59890924; FEMII012A/ 59801792,59867064, 59884766 & 59884778 FEMII012AT/59852940 & 59867051; and FEMII012V/59723307, 59796683, 59849124 & 59873252
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS I | Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
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