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Open, Classified

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

FDA Recall Z-1048-2023 · Posted 2023-02-01

Recalling FirmW L Gore & Associates, Inc.
Recall StatusOpen, Classified
Product CodeMLV
Date Initiated2022-12-14
Product Quantity14

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.

Firm 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]

Root Cause

Employee error

Distribution Pattern

US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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