FDASeptember 30, 2022device

TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..

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

The hazard

Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.

What to do

FDA enforcement status: Ongoing

Brands named

lemaitre vascularlemaitre

Recall history

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

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