Recall Z-0228-2023— LeMaitre Vascular, Inc.

Name: FDA recall Z-0228-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-30

Class II · Ongoing

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2022-09-30. It names one FDA 510(k) clearance: K992368. 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... Reason: 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..

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-30
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K992368 — LEMAITRE EMBOLECTOMY CATHETERVascutech, Inc.·cleared 1999-12-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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..

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.