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..
FDA Recall Z-0228-2023 · Posted 2022-11-11
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Recalling FirmLeMaitre Vascular, Inc.
Recall StatusOpen, Classified
Product CodeDXE
Date Initiated2022-09-30
Product Quantity72 (OUS only)
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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