LeMaitre Embolectomy CatheterRecalls & reported problems across all models
Lemaitre Vascular, Inc. · 47 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one LeMaitre Embolectomy Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 438
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 2
We found 47 models of LeMaitre Embolectomy Catheter by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 438 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2016 and Sep 29, 2026 — classified as 14 injuries, 424 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (301 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
LeMaitre Embolectomy Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · Recall details · FDA record ↗
- 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 · names 22 of these models · Recall details · FDA record ↗
Most reported LeMaitre Embolectomy Catheter problems
Device problems
- Material Rupture301
- Deflation Problem41
- Failure to Deflate35
- Material Separation18
- Device Dislodged or Dislocated8
- Inflation Problem7
- Detachment Of Device Component5
- Unintended Movement5
Patient problems
- No Clinical Signs, Symptoms or Conditions347
- No Known Impact Or Consequence To Patient33
- No Consequences Or Impact To Patient21
- No Information14
- Foreign Body In Patient9
- No Patient Involvement4
- Device Embedded In Tissue or Plaque3
- Administration Site Reaction1
LeMaitre Embolectomy Catheter models
47 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LeMaitre Embolectomy Catheter 1651-88Catheter, Embolectomy1 recall161 reports
- LeMaitre Embolectomy Catheter e1651-88Catheter, Embolectomy2 recalls4 reports
- LeMaitre Embolectomy Catheter 1651-44Catheter, Embolectomy1 recall38 reports
- LeMaitre Embolectomy Catheter 1651-84Catheter, Embolectomy1 recall23 reports
- LeMaitre Embolectomy Catheter 1651-38Catheter, Embolectomy1 recall19 reports
- LeMaitre Embolectomy Catheter 1651-48Catheter, Embolectomy1 recall15 reports
- LeMaitre Embolectomy Catheter e1651-84Catheter, Embolectomy1 recall14 reports
- LeMaitre Embolectomy Catheter 1651-34Catheter, Embolectomy1 recall8 reports
- LeMaitre Embolectomy Catheter 1651-78Catheter, Embolectomy1 recall4 reports
- LeMaitre Embolectomy Catheter 1651-68Catheter, Embolectomy1 recall3 reports
- LeMaitre Embolectomy Catheter e1651-38Catheter, Embolectomy1 recall1 report
- LeMaitre Embolectomy Catheter e1651-44Catheter, Embolectomy1 recall1 report
- LeMaitre Embolectomy Catheter 1651-54Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter 1651-58Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter 1651-64Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter e1651-34Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter e1651-48Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter e1651-54Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter e1651-58Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter e1651-64Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter e1651-68Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter e1651-78Catheter, Embolectomy1 recall0 reports
- LeMaitre Embolectomy Catheter 1601-48Catheter, Embolectomy24 reports
- LeMaitre Embolectomy Catheter 1601-44Catheter, Embolectomy22 reports
- LeMaitre Embolectomy Catheter 1601-38Catheter, Embolectomy16 reports
- LeMaitre Embolectomy Catheter 1801-48Catheter, Embolectomy12 reports
- LeMaitre Embolectomy Catheter e1601-48Catheter, Embolectomy11 reports
- LeMaitre Embolectomy Catheter 1601-58Catheter, Embolectomy9 reports
- LeMaitre Embolectomy Catheter 1801-58Catheter, Embolectomy9 reports
- LeMaitre Embolectomy Catheter e1801-44Catheter, Embolectomy6 reports
- LeMaitre Embolectomy Catheter e1801-48Catheter, Embolectomy5 reports
- LeMaitre Embolectomy Catheter 1601-28Catheter, Embolectomy4 reports
- LeMaitre Embolectomy Catheter 1801-38Catheter, Embolectomy4 reports
- LeMaitre Embolectomy Catheter e1601-26Catheter, Embolectomy3 reports
- LeMaitre Embolectomy Catheter 1801-26Catheter, Embolectomy3 reports
- LeMaitre Embolectomy Catheter e1801-38Catheter, Embolectomy3 reports
- LeMaitre Embolectomy Catheter 1601-68Catheter, Embolectomy2 reports
- LeMaitre Embolectomy Catheter e1601-38Catheter, Embolectomy2 reports
- LeMaitre Embolectomy Catheter 1801-34Catheter, Embolectomy2 reports
- LeMaitre Embolectomy Catheter 1801-44Catheter, Embolectomy2 reports
- LeMaitre Embolectomy Catheter e1801-34Catheter, Embolectomy2 reports
- LeMaitre Embolectomy Catheter 1601-26Catheter, Embolectomy1 report
- LeMaitre Embolectomy Catheter 1601-34Catheter, Embolectomy1 report
- LeMaitre Embolectomy Catheter e1601-24Catheter, Embolectomy1 report
- LeMaitre Embolectomy Catheter e1601-44Catheter, Embolectomy1 report
- LeMaitre Embolectomy Catheter 1801-78Catheter, Embolectomy1 report
- LeMaitre Embolectomy Catheter e1801-26Catheter, Embolectomy1 report
Recent LeMaitre Embolectomy Catheter adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionAug 26, 2026Material Rupture
It was reported that the TufTex OTW balloon ruptured during a procedure. The device was pre-checked prior to use. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453451 ↗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 ↗
Other Lemaitre Vascular, Inc. products
- Pruitt F3 Carotid Shunt10 models · 305 reports
- Artegraft Vascular Graft15 models · 25 reports · 3 recalls
- Trivex System3 models · 69 reports
- Syntel Silicone OTW Embolectomy Catheter8 models · 66 reports
- Syntel Silicone Thrombectomy Catheter5 models · 6 reports · 1 recall
- Pruitt Occlusion Catheter6 models · 5 reports · 1 recall
- Pruitt Irrigation Occlusion Catheter2 models · 4 reports · 1 recall
- LifeSpan ePTFE Vascular Graft10 models · 27 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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