Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PASCAL Precision Transcatheter Valve Repair System Recalled by Edwards Lifesciences, LLC Due to Due to a manufacturing issue, when using valve...
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
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Quantity: 92
Why Was This Recalled?
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.
Where Was This Sold?
International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.
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