Recall Z-0995-2020 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
W. L. Gore & Associates Inc.
GORE EXCLUDER AAA Endoprosthesis
| Date | Jan 6, 2020 |
| Status | Terminated |
| Reason | Firm has received reports of leading end catheter component separations. |
| Root cause | Employee error |
| Action | The recall consists of corrections with no proposed product removal. The correction will consist of: A Medical Device Safety Correction letter sent to US physicians and hospitals and OUS hospitals and Distributors, along with an IFU Summary of Changes document Updates to the products Instruction for Use Updates to physician didactic training Additional manufacturing process error-proofing The firm is also instructing customers to share the letter with others in their hospital or clinic as appropriate, and contact the firm's Customer Service (email: MPDCustomerCare@wlgore.com or by phone a |
| Quantity | 255861 units |
| Distribution | US: OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; Net |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.