Z-0136-2023Class II

GORE CARDIOFORM ASD Occluder. cardiovascular implant

Name: Z-0136-2023 GORE CARDIOFORM ASD Occluder. cardiovascular implant
Creator: W L Gore & Associates, Inc.
Published: 2022-09-21
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2022-09-21 / Open, Classified / root cause: manufacturing process

FDA source

W L Gore & Associates, Inc. began a recall of GORE CARDIOFORM ASD Occluder. cardiovascular implant on 2022-09-21. FDA classified it as Class II and gives the reason as "Due to manufacturing records (Release Test Results) indicating "Failed"". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0136-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-21
Posted: 2022-10-26
Recalling firm: W. L. Gore & Associates, Inc.
Product: GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Product code: MLV Transcatheter Septal Occluder
Reason for recall: Due to manufacturing records (Release Test Results) indicating "Failed".
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Between 09/21-32/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL/FIELD SAFETY NOTICE" via FedEx 2nd Day (U.S.), Postal Mail (EMEA), and Personal Delivery (Japan), informing customers that W.L. Gore & Associates (Gore) identified devices that were incorrectly released following a documented failure of a subset of quality tests. A failure of the subset of quality tests could potentially result in increased risks during the release of the device from the delivery system for the affected devices. Customer are instructed to: Identify and return any unused devices within the scope of this recall. Complete and sign the enclosed CUSTOMER RESPONSE FORM and return to [email protected] within 2 weeks of receipt of this notification. Share this letter with others in their institution as appropriate. Transfer this notice to other organization(s) as appropriate. If a listed device has been used, there is no patient follow-up needed and no further actions required other than informing Gore the device was used. Indicate the used device(s) on the CUSTOMER RESPONSE FORM and return to [email protected]. For questions, contact Gore Customer Service via email - [email protected]
Quantity in commerce: 98 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0136-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0136-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-26

Product code MLV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)