W L Gore & Associates, Inc. GORE CARDIOFORM Septal Occluder, REF: GSX0030A Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Brand
W L Gore & Associates, Inc.
Lot Codes / Batch Numbers
UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406
Products Sold
UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406
W L Gore & Associates, Inc. is recalling GORE CARDIOFORM Septal Occluder, REF: GSX0030A due to Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 FieldActionTeam@wlgore.com 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 MPDCustomerCare@wlgore.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026