Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled by Edwards Lifesciences, LLC Due to Potential device damage on the strain relief near...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edwards Lifesciences, LLC directly.
Affected Products
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
Quantity: 3,360 units.
Why Was This Recalled?
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Edwards Lifesciences, LLC
Edwards Lifesciences, LLC has 94 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report