Z-0228-2023Class II

TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is...

Name: Z-0228-2023 TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is...
Creator: LeMaitre Vascular, Inc.
Published: 2022-09-30
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2022-09-30 / Open, Classified / root cause: manufacturing process

FDA source

LeMaitre Vascular, Inc. began a recall of 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... on 2022-09-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0228-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-30
Posted: 2022-11-11
Recalling firm: LeMaitre Vascular Inc.
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..
Product code: DXE Catheter, Embolectomy
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lots XSL0097, XSL0098, and XSL0099

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0228-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0228-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11

Product code DXE

K992368Class IILemaitre Embolectomy CatheterVascutech, Inc. / cleared 1999-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)