# FDA recall Z-2479-2023

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2023-07-27.

## 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

- **Recall number:** Z-2479-2023
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-27
- **Report date:** 2023-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2479-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2479-2023. Source: US FDA. Licensed CC0.

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