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Terminated

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

FDA Recall Z-0048-2018 · Posted 2017-10-25

Recalling FirmW L Gore & Associates, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2017-09-25
Date Terminated2019-08-27
Product Quantity12,197units

Reason for Recall

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

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, 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

Distribution Pattern

Worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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