LeMaitre Embolectomy Catheter 1651-88Recalls & reported problems
Lemaitre Vascular, Inc. · 5F Plus 80CM Over-the-Wire Embolectomy Catheter · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This LeMaitre embolectomy catheter is a balloon catheter used to remove clots from blood vessels. The 162 reports are all malfunctions, mostly describing the balloon rupturing during procedures, and include no deaths or injuries. There is 1 open recall, started in April 2025, over packages that may have incomplete seals found in internal testing.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 161
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 00840663100750), received between May 22, 2018 and Sep 29, 2026 — classified as 161 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (149 reports).
1 FDA recall record name this device's identifier, 1 still open.
10 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Material Rupture149
- Deflation Problem4
- Failure to Deflate3
- Burst Container or Vessel2
- Material Integrity Problem2
- Material Puncture/Hole1
- Material Separation1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions152
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient3
- Administration Site Reaction1
Recent adverse event reports
The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935643 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919477 ↗MalfunctionAug 26, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50447997 ↗MalfunctionAug 25, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50430182 ↗MalfunctionAug 25, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50429286 ↗MalfunctionAug 25, 2026Material Rupture
It was reported that the TufTex OTW balloon ruptured during the procedure. The device was pre-checked prior to use. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50428555 ↗MalfunctionAug 25, 2026Material Rupture
It was reported that the TufTex OTW balloon ruptured during the procedure. The device was pre-checked prior to use. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50428329 ↗MalfunctionAug 25, 2026Material Rupture
It was reported that the TufTex OTW balloon ruptured during procedure. The device was pre-checked prior to use. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50428193 ↗MalfunctionAug 25, 2026Material Rupture
It was reported that the TufTex OTW balloon ruptured during an embolectomy procedure. The device was pre-checked prior to use. No patient injury was reported. Note: This is report 2 of 2 related to the second catheter used in the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50427715 ↗MalfunctionAug 25, 2026Material Rupture
It was reported that the TufTex OTW balloon ruptured during an embolectomy procedure. The device was pre-checked prior to use. No patient injury was reported.Note: This is report 1 of 2 related to the first catheter used in the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50427388 ↗MalfunctionMay 26, 2026Material Rupture
IT WAS REPORTED THAT THREE (3) TUFTEX OTW BALLOON RUPTURED WHILE REMOVING A BLOOD CLOT DURING A PROCEDURE. THE DEVICES WERE CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 3 OF 3 RELATED TO THE THIRD CATHETER USED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280529 ↗MalfunctionMay 26, 2026Material Rupture
IT WAS REPORTED THAT THREE (3) TUFTEX OTW BALLOON RUPTURED WHILE REMOVING A BLOOD CLOT DURING A PROCEDURE. THE DEVICES WERE CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 2 OF 3 RELATED TO THE SECOND CATHETER USED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279476 ↗MalfunctionMay 26, 2026Material Rupture
IT WAS REPORTED THAT THREE (3) TUFTEX OTW BALLOON RUPTURED WHILE REMOVING A BLOOD CLOT DURING A PROCEDURE. THE DEVICES WERE CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 1 OF 3 RELATED TO THE FIRST CATHETER USED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278313 ↗MalfunctionMay 19, 2026Material Rupture
IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING USE IN A PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225196 ↗MalfunctionMay 19, 2026Material Rupture; Unraveled Material
IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED AND THE LIGATURE UNRAVELED DURING USE IN A PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225081 ↗MalfunctionMay 19, 2026Material Rupture
IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING USE IN A PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25224801 ↗MalfunctionMay 7, 2026Material Rupture
IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING USE IN A PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110348 ↗MalfunctionApr 29, 2026Material Rupture
IT WAS REPORTED THAT THE BALLOON RUPTURED DURING PRE-USE TESTING. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT PRODUCT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25026764 ↗MalfunctionApr 28, 2026Material Rupture
IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED WHILE REMOVING A BLOOD CLOT DURING A PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017008 ↗MalfunctionApr 28, 2026Material Rupture
IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING USE IN A PROCEDURE. IT WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016983 ↗MalfunctionApr 28, 2026Material Rupture
IT WAS REPORTED THAT TWO (2) TUFTEX OTW CATHETERS EXPERIENCED BALLOON RUPTURE WHILE REMOVING A BLOOD CLOT DURING A PROCEDURE. THE DEVICES WERE CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016416 ↗MalfunctionApr 28, 2026Material Rupture
IT WAS REPORTED THAT TWO (2) TUFTEX OTW CATHETERS EXPERIENCED BALLOON RUPTURE WHILE REMOVING A BLOOD CLOT DURING A PROCEDURE. THE DEVICES WERE CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016180 ↗MalfunctionApr 21, 2026Material Rupture
IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING A PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940136 ↗MalfunctionApr 21, 2026Material Rupture
IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING A PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940116 ↗MalfunctionApr 16, 2026Material Rupture
IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED WHILE REMOVING A BLOOD CLOT DURING A PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901901 ↗
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-0117-2027 · Aug 28, 2026 · Open, ClassifiedTufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
- Z-1567-2020 · Mar 23, 2020 · Open, ClassifiedLeMaitre 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-0382-2016 · Oct 21, 2015 · TerminatedLeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
- Z-0378-2016 · Oct 21, 2015 · TerminatedLeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
- Z-0381-2016 · Oct 21, 2015 · TerminatedLeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
- Z-0384-2016 · Oct 21, 2015 · TerminatedLeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
- Z-0380-2016 · Oct 21, 2015 · TerminatedLeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
- Z-0385-2016 · Oct 21, 2015 · TerminatedLeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
- Z-0383-2016 · Oct 21, 2015 · TerminatedLeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
- Z-0379-2016 · Oct 21, 2015 · TerminatedLeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Other Catheter, Embolectomy devices
- Indigo System CAT6Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths408 reports
- Indigo System CATRXKITPenumbra, Inc. · Catheter, Embolectomy1 death339 reports
- Fogarty 120804FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall1 death200 reports
- FOGARTY 120404FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall61 reports
- Indigo System CAT6KIT-APenumbra, Inc. · Catheter, Embolectomy109 reports
- LeMaitre Embolectomy Catheter e1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy2 recalls4 reports
- Indigo System CAT8XTORQ115Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths98 reports
- Fogarty 120805FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall45 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.