Home / Recalls / Medical Devices
Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Recalled September 6, 2023 · FDA recall Z-2479-2023 · Edwards Lifesciences
Hazard
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. · FDA Class II
Units
92
Sold at
International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.
Description
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.
Product
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →