TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Summary
The FDA issued a Class II for TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88; by LeMaitre Vascular, Inc.. Reason: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing..
Details
Source
Device Recall
External ID
Z-0117-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Lot/Code Info: Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
Quantity Affected: 54
Reason for Recall
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Distribution
US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-28
Company
Burlington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
LeMaitre Vascular, Inc. has 12 FDA actions in our database, including 11 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LeMaitre Vascular, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LeMaitre Vascular, Inc. have FDA actions?
LeMaitre Vascular, Inc. has 12 FDA actions in our database, including 11 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0117-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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