Edwards Lifesciences Recalls Fem-Flex II Pediatric Femoral Arterial Cannulas
Edwards Lifesciences is recalling specific sizes of the Fem-Flex II Pediatric Femoral Arterial Cannula due to a protruding wire at the tip that could cause tissue damage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies a risk of tissue damage without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Edwards Lifesciences, LLC is recalling the Fem-Flex II Pediatric Femoral Arterial Cannula in sizes 8, 10, and 12 French. The recall involves 5,125 units that were distributed nationwide. The affected model numbers include FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V.
The recall is being conducted because of the potential for tissue damage caused by a protruding wire located at the tip of the cannula. These devices are intended to provide a means of draining blood flow or perfusing blood into the body of a patient during cardiopulmonary bypass procedures.
Healthcare providers and facilities should check their inventory for the specific model and lot numbers listed in the recall notice. If the affected devices are found, they should be removed from service and returned to Edwards Lifesciences or the distributor as directed.
The recalled product
- 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
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 5,125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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