TufTex Embolectomy Catheter, Model No recallZ-0228-2023 · LeMaitre Vascular, Inc. · initiated Sep 30, 2022
Class II Open, Classified All recalls posted in November 2022
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from LeMaitre Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0228-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Sep 30, 2022
- Posted by the FDA
- Nov 11, 2022
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 72 (OUS only)
- Product code
- DXE
- FDA submissions
- K992368
- Distribution
- No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
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..
Code information (models, lots, serial numbers)
Lots XSL0097, XSL0098, and XSL0099
Other devices under the same FDA submission
25 devices cleared under K992368 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LeMaitre Embolectomy Catheter 1601-48Lemaitre Vascular, Inc. · Catheter, Embolectomy24 reports
- LeMaitre Embolectomy Catheter 1601-44Lemaitre Vascular, Inc. · Catheter, Embolectomy22 reports
- LeMaitre Embolectomy Catheter 1601-38Lemaitre Vascular, Inc. · Catheter, Embolectomy16 reports
- LeMaitre Embolectomy Catheter 1801-48Lemaitre Vascular, Inc. · Catheter, Embolectomy12 reports
- LeMaitre Embolectomy Catheter e1601-48Lemaitre Vascular, Inc. · Catheter, Embolectomy11 reports
- LeMaitre Embolectomy Catheter 1601-58Lemaitre Vascular, Inc. · Catheter, Embolectomy9 reports
- LeMaitre Embolectomy Catheter 1801-58Lemaitre Vascular, Inc. · Catheter, Embolectomy9 reports
- LeMaitre Embolectomy Catheter e1801-44Lemaitre Vascular, Inc. · Catheter, Embolectomy6 reports
- LeMaitre Embolectomy Catheter e1801-48Lemaitre Vascular, Inc. · Catheter, Embolectomy5 reports
- LeMaitre Embolectomy Catheter 1601-28Lemaitre Vascular, Inc. · Catheter, Embolectomy4 reports
- LeMaitre Embolectomy Catheter 1801-38Lemaitre Vascular, Inc. · Catheter, Embolectomy4 reports
- LeMaitre Embolectomy Catheter e1601-26Lemaitre Vascular, Inc. · Catheter, Embolectomy3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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