FDA recall Z-2479-2023

Product

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.

Distribution

International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.

Key facts

Status

Ongoing

Initiation date

2023-07-27

Report date

2023-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2479-2023