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

Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible

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