Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae Recalled by Edwards Lifesciences, LLC Due to Two unsealed pouches were found at an Edwards'...
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 Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.
Quantity: 379 units
Why Was This Recalled?
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
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