FDA-Device2023-09-06Class II
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Edwards Lifesciences, LLC
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.
Sold states
International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.
Affected count
92
Manufactured in
1 Edwards Way, N/A, Irvine, CA, United States
Products
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2479-2023Don't want to check this manually?
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