GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- Company
- W L Gore & Associates, Inc.
- Recall Initiated
- December 14, 2022
- Posted
- February 1, 2023
- Recall Number
- Z-1048-2023
- Quantity
- 14
- Firm Location
- Flagstaff, AZ
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
US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
Lot / Code Info
UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406
Root Cause
Employee error
Action Taken
On 12/14/22, recall notices were mailed to customers informing them to take the following actions: 1) Identify and return any unused devices. 2) Complete and return the customer response form to to FieldActionTeam@wlgore.com 3) This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred. Customers with questions can contact the firm at MPDCustomerCare@wlgore.com