Recall Z-0048-2018 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
W L Gore & Associates, Inc.
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
| Date | Oct 25, 2017 (initiated Sep 25, 2017) |
| Status | Terminated |
| Reason | Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm contact their consignee with a safety notice by letter on 09/25/2017. Gore is updating its Instructions for Use (IFU) to include the following new warnings and precautions: " If abnormal or inconsistent deployment line resistance is felt during deployment initiation, STOP deployment action immediately. If device remains constrained, remove device through the introducer sheath. If resistance is felt during removal through the sheath, stop and withdraw device and introducer sheath together. " If the device is in a partially deployed state and remains attached to the catheter, phys |
| Quantity | 12,197units |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.