GORE CARDIOFORM Septal Occluder recallZ-1048-2023 · W L Gore & Associates, Inc. · initiated Dec 14, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from W L Gore & Associates, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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]
Recall details
- Recall number
- Z-1048-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 14, 2022
- Posted by the FDA
- Feb 1, 2023
- Recalling firm
- W L Gore & Associates, Inc.
- Quantity
- 14
- Product code
- MLV
- Distribution
- US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
Product description
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Code information (models, lots, serial numbers)
UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GORE CARDIOFORM Septal Occluder GSX0030AW. L. Gore & Associates, Inc. · Transcatheter Septal Occluder1 recall143 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page