FDADecember 17, 2019device

Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.

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

The hazard

The incorrect label was placed on both the primary and secondary package.

What to do

FDA enforcement status: Terminated

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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