Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Recalled by Edwards Lifesciences, LLC Due to SAPIEN 3 THV was packaged with the incorrect...
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 SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Quantity: 1 Valve
Why Was This Recalled?
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Where Was This Sold?
This product was distributed to 1 state: NJ
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