GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair

FDA device recall Z-0048-2018 · posted 2017-10-25 · Terminated

Recall details

Recalling firm

W L Gore & Associates, Inc.

Reason for recall

Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.

Action taken

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, physicians should strongly consider conversion to immediate open surgical repair to avoid additional procedure time and potential harm from additional endovascular maneuvers.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

MIH

Quantity affected

12,197units

Distribution

Worldwide.

Date initiated

2017-09-25

Date posted

2017-10-25

Date terminated

2019-08-27

Location

Flagstaff, AZ