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

Official notice

14 Oct 2026

Last checked

20 Oct 2026

MediumFDA

An official FDA notice concerns TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-10-14. Lots: XOT00002181. Recall numbers: Z-0117-2027. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

54

Recall number

Z-0117-2027

Official notice

2026-10-14

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

XOT00002181

Other

UDI-DI 00840663100866

Event Ids

99836

Recall Numbers

Z-0117-2027

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Affected products

Product 1

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

Units affected

54

Risk / hazard

Health risk requiring medical assessment

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Lemaitre Vascular. Contact: LeMaitre Vascular, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0117-2027

Event id

99836

Units affected

54

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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