Edwards FEM-FLEX II Femoral Cannula Recalled for Exposed Wire Defect
Edwards Lifesciences is recalling the FEM-FLEX II Femoral Arterial Cannula due to exposed wire segments protruding from the device body. The defect poses a mechanical hazard during arterial perfusion procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the recall rubric. Although no injuries or deaths are reported in the source, the exposed protruding wire on an arterial cannula creates a mechanical hazard during critical extracorporeal perfusion procedures.
Plain-English summary
Edwards Lifesciences, LLC is recalling the FEM-FLEX II Femoral Arterial Cannula (Model FEMII016AS). This medical device is used to establish arterial perfusion in extracorporeal circuits. The recall affects 847 units distributed worldwide and throughout all 50 U.S. states, Puerto Rico, and multiple international locations.
The FDA has classified this recall as Class I due to complaints regarding a manufacturing defect: exposed or protruding wire segments measuring 3 to 4 millimeters extending from the outside of the cannula body. The protruding wire poses a potential safety hazard during device use.
Affected devices are identified by Model Number FEMII016AS, UDI 0060913168341, and lot codes up to BSLC1689. Healthcare facilities and clinicians currently using these cannulas should immediately cease use and contact Edwards Lifesciences for replacement or remediation instructions.
The recalled product
- 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.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- exposed-wire
- manufacturing-defect
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 (4)
- Lot Code: Model No
- FEMII016AS
- UDI: 0060913168341
- All lots up to: BSLC1689 Serial Numbers: FEMII016AS FEMII016AS FEMII016AS
Distribution
Distributed nationwide across the United States.
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