# FDA recall Z-0228-2023

> **LeMaitre Vascular, Inc.** · Class II · device recall initiated 2022-09-30.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0228-2023
- **Recalling firm:** LeMaitre Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-30
- **Report date:** 2022-11-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burlington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0228-2023

## Citation

> AI Analytics. FDA recall Z-0228-2023. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0228-2023. Source: US FDA. Licensed CC0.

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