CLASS II ONGOING Device recall · Reported 8 Feb 2023 · FDA Enforcement Report

Gore Cardioform Septal Occluder recalled by W L Gore & Associates

W L Gore & Associates is recalling Gore Cardioform Septal Occluder, distributed nationwide in the US. The recall was initiated on 14 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406

Quantity recalled14

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1048-2023
FDA event ID: 91380
Recalling firm: W L Gore & Associates, Flagstaff, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 14 Dec 2022
FDA classified: 1 Feb 2023
Reported: 8 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

14 Dec 2022	Recall initiated by company
1 Feb 2023	Classified by FDA	+49 days
8 Feb 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

Where it was distributed

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

Nationwide Arkansas California Connecticut Florida Indiana Massachusetts Missouri New York South Dakota Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from W L Gore & Associates

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19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
8 Jul 2026Device	CLASS II	GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled	W L Gore & Associates	Other	Nationwide
8 Oct 2025Device	CLASS II	Gore Acuseal Vascular Graft recalled by W L Gore & Associates	W L Gore & Associates	Packaging Defects	51 states
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