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..
This recall is currently active, issued November 11, 2022. It was issued by Lemaitre Vascular, Inc..
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- September 30, 2022
- Posted
- November 11, 2022
- Recall Number
- Z-0228-2023
- Quantity
- 72 (OUS only)
- Firm Location
- Burlington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
Lot / Code Info
Lots XSL0097, XSL0098, and XSL0099
Root Cause
Process design
Action Taken
On September 30, 2022, the recalling firm notified affected customers via Urgent Field Safety Notice letters. Users were instructed to immediately identify, quarantine, and return the affected devices.