FDAJanuary 29, 2020device

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

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

The hazard

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

What to do

FDA enforcement status: Terminated

Brands named

abbott vascularabbott

UPCs

08717648196027

Recall history

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

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