CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

TufTex¿ Over-the-Wire Embolectomy Catheter recalled

LeMaitre Vascular is recalling TufTex¿ Over-the-Wire Embolectomy Catheter, distributed nationwide in the US. The recall was initiated on 28 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;

Quantity recalled54

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0117-2027
FDA event ID: 99836
Recalling firm: LeMaitre Vascular, Burlington, MA
Classification: Class II
Status: Ongoing
Recall initiated: 28 Aug 2026
FDA classified: 7 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

28 Aug 2026	Recall initiated by company
7 Oct 2026	Classified by FDA	+40 days
14 Oct 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.

Nationwide California Florida Georgia Kentucky Louisiana New Jersey Ohio Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from LeMaitre Vascular

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29 Oct 2025Device	CLASS II	Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Packaging Defects	AR
15 Oct 2025Device	CLASS II	Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular	LeMaitre Vascular	Labeling Errors	NJ
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