Use caution Medical device recall · FDA · Published July 27, 2023

Edwards Lifesciences PASCAL Valve Repair System Recall: Release Knob Resistance Risk

Edwards Lifesciences recalls PASCAL Precision Transcatheter Valve Repair System models 20000ISM and 20000IS due to potential resistance when releasing implants, which could cause improper rotation or additional implantation.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2479-2023Medical device Edwards Lifesciences ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmEdwards Lifesciences, LLC1 Edwards Way · Irvine, CA 92614-5688

✎ GovInfoNow plain-language explainer

Edwards Lifesciences is recalling two specific models of PASCAL Precision Transcatheter Valve Repair Systems because they can cause resistance when releasing the implant from the delivery system. This resistance might lead to the implant rotating incorrectly or being implanted improperly, which could affect the repair's effectiveness. Read more at govinfonow.com/recall/57582-edwards-lifesciences-pascal-valve-repair-system-recall-release-knob-resistance.

Source Summary by GovInfoNow · govinfonow.com/recall/57582-edwards-lifesciences-pascal-valve-repair-system-recall-release-knob-resistance · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2479-2023

Cite this page

“Edwards Lifesciences PASCAL Valve Repair System Recall: Release Knob Resistance Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57582-edwards-lifesciences-pascal-valve-repair-system-recall-release-knob-resistance. Based on FDA recall #Z-2479-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2479-2023%22&limit=1).

Edwards Lifesciences, LLC voluntarily recalled its PASCAL Precision Transcatheter Valve Repair Systems due to a manufacturing issue causing resistance when releasing the implant, according to the FDA on July 27, 2023.

How to tell if you have it

Brand: Edwards Lifesciences
Product: PASCAL Precision Transcatheter Valve Repair System
Models: 20000ISM and 20000IS
Basic-UDI Code: 0690103S004PAS000BC

The hazard

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 could cause implant rotation or additional implantation.

Context

GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since July 6, 2017. Other recent recalls include the Edwards EVOQUE Tricuspid Delivery System Recall on March 27, 2026, and the Optisite Arterial Cannula Recall on May 14, 2025. Similar product recalls include the Olympus HX-400U-30 Ligating Device Recall on October 30, 2025, and the Merit Medical Allwell Angioplasty Pack Recall on December 4, 2025.

How to tell if you have this one

Check for model numbers 20000ISM or 20000IS on the device packaging or labels. The Basic-UDI Code starts with 0690103S004PAS000BC. These models were sold with specific serial numbers listed in the recall notice.

Brand
Edwards Lifesciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for model numbers 20000ISM or 20000IS on the device packaging or labels.
Contact Manufacturer
Reach out to Edwards Lifesciences directly for guidance on next steps if you have the recalled model.

How this recall unfolded

Recall timeline

FDA published this recall 41 days after the firm started it.

Jul 27, 2023Firm started the recall
Aug 29, 2023FDA classified it Class II
Sep 6, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/57582-edwards-lifesciences-pascal-valve-repair-system-recall-release-knob-resistance">Edwards Lifesciences PASCAL Valve Repair System Recall: Release Knob Resistance Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2479-2023 (July 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2479-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.