Edwards FEM-FLEX II Femoral Arterial Cannula Recalled for Exposed Wire
Edwards Lifesciences recalls the FEM-FLEX II Femoral Arterial Cannula due to exposed wire protruding from the device body that could cause vascular injury.
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: The FDA classified this recall as Class I, indicating a serious health hazard that warrants a minimum severity score of 4 per the rubric. No reported injuries, illnesses, or deaths are documented in the source material.
Plain-English summary
Edwards Lifesciences, LLC is recalling the FEM-FLEX II Femoral Arterial Cannula (Model FEMII018A) due to complaints of exposed or protruding wire sections measuring 3mm to 4mm on the outside of the cannula body. This defect was identified through customer complaints and could pose a serious risk during use in extracorporeal perfusion procedures.
The recall affects approximately 13,240 units that have been distributed worldwide, including across the United States and internationally. Affected lots are identified by specific serial numbers and lot codes provided in the FDA recall notice.
Healthcare providers and patients who have received or are using this device should contact Edwards Lifesciences for replacement or return instructions. Any concerns about prior device use should be discussed with the patient's healthcare provider.
The recalled product
- 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.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- exposed-wire
- vascular-injury-risk
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 (2)
- Lot Code: Model No: FEMII018A
- UDI: 0069013031256
Distribution
Distributed nationwide across the United States.
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