LeMaitre Vascular, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0228-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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..

Product Classification:

Class II

Date Initiated: September 30, 2022

Date Posted: November 23, 2022

Recall Number: Z-0228-2023

Event ID: 91006

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.

Status: Ongoing

Product Quantity: 72 (OUS only)

Code Information:

Lots XSL0097, XSL0098, and XSL0099

Distribution Pattern:

No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.

Voluntary or Mandated:

Voluntary: Firm initiated