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U.S. Department of Health and Human Services

Class 2 Device Recall TufTex Embolectomy Catheter

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  Class 2 Device Recall TufTex Embolectomy Catheter see related information
Date Initiated by Firm September 30, 2022
Date Posted November 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-0228-2023
Recall Event ID 91006
510(K)Number K992368  
Product Classification Catheter, embolectomy - Product Code DXE
Product 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..
Code Information Lots XSL0097, XSL0098, and XSL0099
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
32 3rd Ave
Burlington MA 01803-4414
For Additional Information Contact Laurie Churchill
781-425-1714
Manufacturer 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.
FDA Determined
Cause 2		 Process design
Action 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.
Quantity in Commerce 72 (OUS only)
Distribution No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXE and Original Applicant = VASCUTECH, INC.
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