PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Reported: September 6, 2023 Initiated: July 27, 2023 #Z-2479-2023
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.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 92
- Distribution
- International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS. Recalled by Edwards Lifesciences, LLC. Units affected: 92.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2479-2023.
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