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Recall Observatory FDA recall evidence

Device product

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

Z-1048-2023

December 14, 2022

Class II

Product summary

Firm
W L Gore & Associates, Inc.
Event
Event 91380
Status
Ongoing
Classification
Class II
Quantity
14
Official record key
device-enforcement:Z-1048-2023

Official wording

Reason: 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.

Code information: UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.