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GORE CARDIOFORM Septal Occluder, REF: GSX0030A

FDA Recall #Z-1048-2023 — Class II — December 14, 2022

Recall #Z-1048-2023 Date: December 14, 2022 Classification: Class II Status: Ongoing

Product Description

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

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.

Recalling Firm

W L Gore & Associates, Inc. — Flagstaff, AZ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

14

Distribution

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

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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