MAUDE Adverse Event Report: LeMaitre Vascular, Inc. TufTex Over-the-Wire Embolectomy Catheter

Catalog Number	e1651-88
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We have determined that (b)(4) units from tuftex® over-the-wire embolectomy catheter lot number: xot00002181 were inadvertently sold to 11 us customers prior to being released.The lot was on hold for an ncmr investigation, where 1 out of 8 samples failed pull testing during manufacturing.It is possible that products from this lot are at a higher risk of experiencing ligature slip resulting in balloon deflation issues or balloon detachment during use.This failure could lead to adverse events during use.However, no complaints have been received related to these devices.Based on the issue, a field corrective action is being initiated by lemaitre to recall these devices (class ii recall).
Additional Manufacturer Narrative
The (b)(4) units from lot: xot00002181 were sold to customers prior to the lot being released for sale.The lot was on hold under an ncmr for further investigation following 1 out of 8 samples failing the pull test during manufacturing with a ligature slip failure mode.It is possible that products from this lot are at a higher risk of experiencing ligature slip resulting in balloon deflation issues or balloon detachment during use.This failure could lead to adverse events during use.

• Brand Name: TufTex Over-the-Wire Embolectomy Catheter
• Common Device Name: Embolectomy Catheter
• Manufacturer (Section D): LeMaitre Vascular, Inc.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LeMaitre Vascular, Inc; 63 second ave; burlington MA 01803
• Manufacturer Contact: jefferey oddy ; 63 second ave; burlington, MA 01803
• MDR Report Key: 50549488
• Report Number: 1220948-2026-00275
• Device Sequence Number: 21426693
• Product Code: DXE
• UDI-Device Identifier: 00840663100866
• UDI-Public: (01)00840663100866(11)250123(17)301228(10)XOT00002181(91)e1651-88
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K022145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: e1651-88
• Device Lot Number: XOT00002181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown