Unrated Medical device recall · FDA · Published September 21, 2022

W L Gore GORE CARDIOFORM ASD Occluder Recall: Failed Manufacturing Test

W L Gore recalls specific GORE CARDIOFORM ASD Occluder implants due to failed manufacturing tests. Affected units have unique model and serial numbers. Consumers should contact the company for details.

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

🇺🇸 FDA recall #Z-0136-2023Medical device W L Gore ›

Recall notice

Due to manufacturing records (Release Test Results) indicating "Failed".

Take action

Contact the company

Recalling firmW L Gore & Associates, Inc.3750 W Kiltie Ln · Flagstaff, AZ 86005-8712

✎ GovInfoNow plain-language explainer

W L Gore is recalling certain GORE CARDIOFORM ASD Occluder cardiovascular implants because manufacturing tests showed they failed. This means the devices may not work safely in the body and could cause health risks. Read more at govinfonow.com/recall/60033-w-l-gore-gore-cardioform-asd-occluder-recall-failed-manufacturing.

Source Summary by GovInfoNow · govinfonow.com/recall/60033-w-l-gore-gore-cardioform-asd-occluder-recall-failed-manufacturing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0136-2023

Cite this page

“W L Gore GORE CARDIOFORM ASD Occluder Recall: Failed Manufacturing Test.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60033-w-l-gore-gore-cardioform-asd-occluder-recall-failed-manufacturing. Based on FDA recall #Z-0136-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0136-2023%22&limit=1).

W L Gore & Associates, Inc. recalled GORE CARDIOFORM ASD Occluders due to manufacturing records indicating failed release test results, the FDA said on Sept. 21, 2022.

How to tell if you have it

Brand: W L Gore
Product: GORE CARDIOFORM ASD Occluder
Model Number: ASD37A, UDI-DI Code: 00733132636501, Serial Numbers: 24468090 24468092 24468093 24468096 24468097 24468098 24468099 24468103 24468104 24480314 24480315 24480316 24480318 24468102 24468094 24468100 24468101 24480317 24468091 24468095
Model Number: ASD44A, UDI-DI Code: 00733132636518, Serial Numbers: 24281498 24281499 24281500 24281501 24281502 24281507 24281509 24281511 24281512 24429270 24429271 24429276 24429278 24429279 24480351 24480352 24480353 24545359 24550148 24550149 24578446 24578447 24281506 24429272 24429273 24429274 24429277 24545360 24545362 24550147 24550150 24550151 24578443 24578445 24281503 24281504 24281505 24281508 24281510 24429275 24480354 24480355 24545358
Model Number: ASD44E, UDI-DI Code: 00733132636617, Serial Numbers: 24305083 24305081 24550693 24550694 24305079 24305080 24305082 24550695 24550696 24550697
Distribution: Worldwide, including U.S. states AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, WI, and countries Denmark, Japan

The hazard

The recall is due to manufacturing records indicating failed release test results for the cardiovascular implant.

Context

GovInfoNow's records show W L Gore & Associates, Inc. has 18 other recalls on record since 2017-09-25. Other recent recalls of similar products include W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (2026-05-22), W L Gore Thoracic Branch Endoprosthesis Side Branch Component Recall (2026-05-19), and W L Gore ACUSEAL Vascular Graft Recall (2025-08-26). Other recent recalls of similar products include AVID Medical Halyard Arteriogram Recall (2025-11-14), Medtronic GUNDRY Cannula Recall (2026-04-21), and Biomerieux VITEK 2 AST-N447 Kit Recall (2026-06-04).

How to tell if you have this one

Check the model number (ASD37A, ASD44A, or ASD44E) and serial numbers listed in the recall notice. The devices are cardiovascular implants used for heart conditions.

Brand
W L Gore
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify your model number and serial number to confirm if it's in the recall list.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 16 states.

FDA distribution: “Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Iowa, Maine, Minnesota, New York, North Carolina, Tennessee, Texas, Washington, Wisconsin.

Recall timeline

FDA published this recall 42 days after the firm started it.

Sep 21, 2022Firm started the recall
Oct 26, 2022FDA classified it Class II
Nov 2, 2022Published in FDA’s Enforcement Report

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

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Keep exploring

More W L Gore recalls

Link to this recall

<a href="https://govinfonow.com/recall/60033-w-l-gore-gore-cardioform-asd-occluder-recall-failed-manufacturing">W L Gore GORE CARDIOFORM ASD Occluder Recall: Failed Manufacturing Test (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-0136-2023 (September 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0136-2023 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.