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..
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.
No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0228-2023