Recall Z-1048-2023 ยท MLV Transcatheter Septal Occluder
W L Gore & Associates, Inc.
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
| Date | Feb 1, 2023 (initiated Dec 14, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Employee error |
| Action | 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 |
| Quantity | 14 |
| Distribution | US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.