GORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation
W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a cardiac device with no reported hospitalizations or confirmed injuries, but poses risk of serious harm including anoxic brain injury and vascular perforation if the undocumented quality test failure occurs. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
The GORE CARDIOFORM Septal Occluder, model GSX0030A, is a cardiac implant device used to close certain heart defects. W L Gore & Associates is recalling 14 units of this device due to incomplete quality test documentation.
The recalled units were released without complete documentation verifying that the device properly releases from its delivery system during the surgical procedure. Without this documented verification, there is a potential risk that the occluder could fail to detach correctly, which could result in serious complications including device embolization (unintended migration within the body), anoxic brain injury, or perforation or rupture of blood vessels.
The affected units were distributed to medical facilities in New York, California, Florida, Connecticut, Texas, Arkansas, Indiana, Massachusetts, Missouri, South Dakota, and Virginia. The specific recalled devices are identified by serial numbers provided in the official recall notice.
Healthcare providers with these units and patients who have received this device should contact W L Gore & Associates immediately to discuss the recall and any necessary follow-up actions.
The recalled product
- Product
- GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Cardiac Implant
- Hazard
- embolization
- anoxic-brain-injury
- vascular-perforation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- UDI-DI/Serial Numbers: 00733132631032/25556388
- 25556389
- 25556390
- 25556391
- 25556392
- 25556393
- 25556394
- 25556398
- 25556399
- 25556400
- 25556401
- 25556402
- 25556403
- 25556406
Distribution
Distributed nationwide across the United States.
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