Z-1048-2023Class II

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

Name: Z-1048-2023 GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Creator: W L Gore & Associates, Inc.
Published: 2022-12-14
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2022-12-14 / Open, Classified / root cause: manufacturing process

FDA source

W L Gore & Associates, Inc. began a recall of GORE CARDIOFORM Septal Occluder, REF: GSX0030A on 2022-12-14. FDA classified it as Class II and gives the reason as "Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could...". 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-1048-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-14
Posted: 2023-02-01
Recalling firm: W. L. Gore & Associates, Inc.
Product: GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Product code: MLV Transcatheter Septal Occluder
Reason for recall: Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 12/14/22, recall notices were mailed to customers informing them to take the following actions: 1) Identify and return any unused devices. 2) Complete and return the customer response form to to [email protected] 3) This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred. Customers with questions can contact the firm at [email protected]
Quantity in commerce: 14
Distribution: US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
Product codes and lots: UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1048-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1048-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-02-01

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)