LeMaitre Embolectomy Catheter e1651-88Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840663100866), received between Apr 18, 2018 and Sep 1, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

9 other recalls cover devices cleared under the same FDA submission (K022145); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 28, 2026Open, Classified

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

   Z-0117-2027 · Root cause: Under Investigation by firm · FDA record ↗

2. Apr 11, 2025Open, Classified

   During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

   Z-1750-2025 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Material Fragmentation; Material Separation

  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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549488 ↗
• MalfunctionFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE DOCTOR EXPERIENCED 3 RECENT BALLOON RUPTURES WITH THE TUFTEX OVER-THE-WIRE CATHETERS. AN OPERATION ON A PATIENT ON (B)(6) 2025 EXPERIENCED 2 RUPTURES AND AN OPERATION ON A PATIENT ON (B)(6) 2025 EXPERIENCED 1 RUPTURE. THIS IS REPORT 3 OF 3 RELATED TO THE CATHETER USED ON THE SECOND PATIENT. IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING THE PROCEDURE. THE RUPTURES EITHER OCCUR ON AN INITIAL PULLBACK OR AFTER THE INITIAL PULLBACK WAS SUCCESSFUL AND A REPEATED PULLBACK IS REQUIRED. NO INJURY WAS REPORTED TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICES WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381718 ↗
• MalfunctionFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE DOCTOR EXPERIENCED 3 RECENT BALLOON RUPTURES WITH THE TUFTEX OVER-THE-WIRE CATHETERS. AN OPERATION ON A PATIENT ON (B)(6) 2025 EXPERIENCED 2 RUPTURES AND AN OPERATION ON A PATIENT ON (B)(6) 2025 EXPERIENCED 1 RUPTURE. THIS IS REPORT 2 OF 3 RELATED TO THE SECOND CATHETER USED ON THE FIRST PATIENT. IT WAS REPORTED THAT THE SECOND TUFTEX OTW BALLOON RUPTURED DURING THE PROCEDURE. THE RUPTURES EITHER OCCUR ON AN INITIAL PULLBACK OR AFTER THE INITIAL PULLBACK WAS SUCCESSFUL AND A REPEATED PULLBACK IS REQUIRED. NO INJURY WAS REPORTED TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381701 ↗
• MalfunctionApr 18, 2018Deflation Problem; Deflation Problem

  AFTER DECLOTTING THE AV FISTULA, THE PHYSICIAN INFLATED THE CATHETER ON THE ARTERIAL SIDE. HOWEVER,THE PHYSICIAN COULD NOT DEFLATE THE BALLOON. HE HAD TO DEFLATE THE BALLOON USING A NEEDLE IN ORDER TO REMOVE THE CATHETER OUT OF THE PATIENT'S ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441565 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022145. One submission often covers many models, so check the product and lot details in each record.

• Z-1567-2020 · Mar 23, 2020 · Open, Classified
  LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the r
• Z-0385-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
• Z-0378-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
• Z-0380-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
• Z-0382-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
• Z-0379-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
• Z-0383-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
• Z-0384-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
• Z-0381-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.