# P040043: Gore Tag Thoracic Endoprosthesis

- Pathway: PMA
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Mar 23, 2005 after 170 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- Device class: 3
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 9, 2020 · Class II · Z-0290-2021: Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
- Sep 9, 2020 · Class II · Z-0291-2021: When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
- Dec 17, 2019 · Class II · Z-2052-2020: The incorrect label was placed on both the primary and secondary package.
- Sep 25, 2017 · Class II · Z-0048-2018: Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
- Apr 28, 2006 · Not classified · Z-1237-06: Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa.
- Apr 28, 2006 · Not classified · Z-1236-06: Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa.

Source page: https://510kreport.com/device/P040043
Methodology: https://510kreport.com/methodology