Z-0117-2027

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

Name: Z-0117-2027 TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88
Creator: LeMaitre Vascular, Inc.
Published: 2026-08-28
License: https://open.fda.gov/license/

LeMaitre Vascular, Inc. / initiated 2026-08-28 / Open, Classified

FDA source

Recall record

Recall number: Z-0117-2027
Status: Open, Classified
Initiated: 2026-08-28
Posted: 2026-10-07
Recalling firm: LeMaitre Vascular, Inc.
Product: TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Product code: DXE Catheter, Embolectomy
Reason for recall: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
FDA root cause: Under Investigation by firm
Action: On August 28, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices. 2. Complete the form at the end of this letter. Please note that you must return the form even if you have no devices in inventory. 3. LeMaitre customer service will provide an RMA number to coordinate the product return. 4. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided. 5. If you have transferred devices to another facility, please forward a copy of this recall letter to them.
Quantity in commerce: 54
Distribution: US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
Product codes and lots: Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;

Product code DXE

K022145Class IIOver the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. / cleared 2003-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)