Recall Z-0136-2023 ยท MLV Transcatheter Septal Occluder
W L Gore & Associates, Inc.
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
| Date | Oct 26, 2022 (initiated Sep 21, 2022) |
| Status | Open, Classified |
| Reason | Due to manufacturing records (Release Test Results) indicating "Failed". |
| Root cause | Employee error |
| Action | Between 09/21-32/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL/FIELD SAFETY NOTICE" via FedEx 2nd Day (U.S.), Postal Mail (EMEA), and Personal Delivery (Japan), informing customers that W.L. Gore & Associates (Gore) identified devices that were incorrectly released following a documented failure of a subset of quality tests. A failure of the subset of quality tests could potentially result in increased risks during the release of the device from the delivery system for the affected devices. Customer are instructed to: Identify and return any unused devices within the scope of this rec |
| Quantity | 98 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.