Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fogarty Thru-Lumen Embolectomy Catheter Recalled by Edwards Lifesciences, LLC Due to Inadvertent release of embolectomy catheters that may experience...
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 Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Quantity: 185
Why Was This Recalled?
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Where Was This Sold?
OUS: Singapore, Taiwan, Canada
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