Recall Z-2479-2023— Edwards Lifesciences, LLC
Class II · Ongoing
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2023-07-27. FDA's recall record names no specific 510(k) clearance for this event. Product: PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS. Reason: 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..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-27
- Firm location
- Irvine, CA, United States
Product description
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.