W L Gore & Associates, Inc. Recall 91380
Description: GORE CARDIOFORM Septal Occluder, REF: GSX0030A
W L Gore & Associates, Inc. Recall 91380 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1048-2023 |
| Event ID | 91380 |
| Event Description | GORE CARDIOFORM Septal Occluder, REF: GSX0030A |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA. |
| Quantity | 14 |
| Recall Reason | 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 Classification | 20230208 |
| Device Code Info | UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406 |
| Center Classification Date | 20230201 |
| Recall Initiation Date | 20221214 |
| Recalling Firm | W L Gore & Associates, Inc. |
| Initial Notification | Letter |
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