GORE CARDIOFORM Septal Occluder recall
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Why was GORE CARDIOFORM Septal Occluder recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406
- Product
- GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- Recalling firm
- W L Gore & Associates, Inc.
- Quantity
- 14
- Distribution
- US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
- Recall date
- February 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)