CLASS II ONGOING Device recall · Reported 2 Nov 2022 · FDA Enforcement Report

Gore Cardioform Asd Occluder recalled by W L Gore & Associates

W L Gore & Associates is recalling Gore Cardioform Asd Occluder, distributed nationwide in the US. The recall was initiated on 21 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: ASD37A UDI-DI Codes: 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

Quantity recalled98 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0136-2023
FDA event ID: 90912
Recalling firm: W L Gore & Associates, Flagstaff, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 21 Sep 2022
FDA classified: 26 Oct 2022
Reported: 2 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Sep 2022	Recall initiated by company
26 Oct 2022	Classified by FDA	+35 days
2 Nov 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

GORE CARDIOFORM ASD Occluder. cardiovascular implant.

Where it was distributed

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.

Nationwide Arizona California Colorado District of Columbia Florida Georgia Iowa Idaho Illinois Maine Minnesota North Carolina New York Tennessee Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model Numbers: ASD37A UDI-DI Codes: 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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from W L Gore & Associates

All 31

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	The Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
8 Jul 2026Device	CLASS II	GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled	W L Gore & Associates	Other	Nationwide
8 Oct 2025Device	CLASS II	Gore Acuseal Vascular Graft recalled by W L Gore & Associates	W L Gore & Associates	Packaging Defects	51 states

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