← FDA ENFORCEMENT
Z-0117-2027Class II

LeMaitre Vascular, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
LeMaitre Vascular, Inc.
Product type
Device
Status
Ongoing
Report date
2026-10-14
Distribution
US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
Firm state
MA
Product quantity
54
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

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

Code / lot info

Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →