Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP Recalled by Edwards Lifesciences, LLC Due to Due to an increase of confirmed latex deterioration...
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
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Quantity: 26,560 units
Why Was This Recalled?
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
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