Z-1048-2023 Class II Ongoing
FDA device recall Z-1048-2023 was initiated by W L Gore & Associates, Inc. on December 14, 2022 and is designated Class II. 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 te… The recall status is ongoing. Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2023
- Initiation Date
- December 14, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
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.
Distribution Pattern
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