FEM-FLEX II Femoral Arterial Cannula recalled for exposed wire defect
Edwards Lifesciences is recalling FEM-FLEX II Femoral Arterial Cannula devices due to exposed or protruding wire sections on the cannula body. Approximately 6,801 units were distributed worldwide.
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: This is an FDA Class I recall, which requires a minimum severity score of 4. The exposed wire defect on a critical medical device used in vascular perfusion circuits presents potential for tissue trauma and contamination.
Plain-English summary
Edwards Lifesciences, LLC is recalling the FEM-FLEX II Femoral Arterial Cannula (Model FEMII016A) due to complaints of exposed or protruding wire sections measuring 3mm to 4mm on the outside of the cannula body.
The affected devices have worldwide distribution, including all US states and Puerto Rico. Approximately 6,801 units are affected, with lot codes designated up to BSLC8179.
The exposed wire defect poses a risk of tissue injury and contamination of the extracorporeal circuit during use. This is a Class I recall, indicating potential for serious adverse health consequences. Healthcare providers and institutions that received these devices should contact Edwards Lifesciences for replacement or return instructions.
The recalled product
- Product
- Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A 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
- wire-protrusion
- tissue-damage
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: FEMII016A
- UDI: 00690103031232
Distribution
Distributed nationwide across the United States.
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