Official recall record
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-07-27
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Edwards Lifesciences, LLC
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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