FDASeptember 9, 2020device

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.

What to do

FDA enforcement status: Ongoing

Brands named

w l gore associates

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System — Recall Details · AllClear