FDA Device recall Z-0228-2023
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion
- FDA Device
- Class II
- ongoing
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion by Lemaitre Vascular, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0228-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-30 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Lemaitre Vascular |
| Distribution | n/a |
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.
Identifiers
| code_info | Lots XSL0097, XSL0098, and XSL0099 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0228-2023%22
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