Recall Z-2052-2020 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
W L Gore & Associates, Inc.
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
| Date | May 20, 2020 (initiated Dec 17, 2019) |
| Status | Terminated |
| Reason | The incorrect label was placed on both the primary and secondary package. |
| Root cause | Labeling Change Control |
| Action | On 12/17/2019, the firm's field representatives hand delivered an URGENT MEDICAL DEVICE RECALL Notification to customers informing them of a label issue with their stents. Two (2) of the 20 units in their work order are labeled with the incorrect part number and size on both the package and carton labels. Customers are instructed to: return the affected products for replacement and If customers have any questions or concern to contact Field Sales Associates for assistance at Telephone number: 03-6746-2560, FAX number: 03-6746-2561 |
| Quantity | 15 stents |
| Distribution | International the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.