Recall Z-0117-2027— LeMaitre Vascular, Inc.

Name: FDA recall Z-0117-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

Class II · Ongoing

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2026-08-28. It names one FDA 510(k) clearance: K022145. Product: TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;. Reason: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing..

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-28
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K022145 — OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302LeMaitre Vascular, Inc.·cleared 2003-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;

Reason for recall

Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.