Syntel Silicone OTW Embolectomy CatheterRecalls & reported problems across all models
Lemaitre Vascular, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 8 models of Syntel Silicone OTW Embolectomy Catheter by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2021 and Sep 29, 2026 — classified as 5 injuries, 61 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (62 reports).
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
Most reported Syntel Silicone OTW Embolectomy Catheter problems
Device problems
- Material Rupture62
- Material Perforation2
- Device Markings/Labelling Problem1
- Inflation Problem1
- Material Puncture/Hole1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions61
- Hemorrhage/Blood Loss/Bleeding5
Syntel Silicone OTW Embolectomy Catheter models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Syntel Silicone OTW Embolectomy Catheter A4E08Catheter, Embolectomy15 reports
- Syntel Silicone OTW Embolectomy Catheter A4E06Catheter, Embolectomy12 reports
- Syntel Silicone OTW Embolectomy Catheter A4E04Catheter, Embolectomy11 reports
- Syntel Silicone OTW Embolectomy Catheter A4E01Catheter, Embolectomy10 reports
- Syntel Silicone OTW Embolectomy Catheter A4E05Catheter, Embolectomy6 reports
- Syntel Silicone OTW Embolectomy Catheter A4E09Catheter, Embolectomy6 reports
- Syntel Silicone OTW Embolectomy Catheter A4E03Catheter, Embolectomy4 reports
- Syntel Silicone OTW Embolectomy Catheter A4E02Catheter, Embolectomy2 reports
Recent Syntel Silicone OTW 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 50936038 ↗MalfunctionMay 13, 2026Material Rupture
IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO PERFORM CLOT RETRIEVAL; HOWEVER, RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL FROM THE UPPER ARM PTFE GRAFT. DURING REMOVAL, THE BALLOON CATHETER BECAME PARTIALLY DISENGAGED FROM THE GUIDEWIRE AND SUBSEQUENTLY FRACTURED INTO TWO PIECES. THE DEVICE WAS ULTIMATELY REMOVED IN SEGMENTS USING A HEMOSTAT. NO ADDITIONAL DEVICE ISSUES OR PATIENT INJURY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162855 ↗MalfunctionApr 9, 2026Material Rupture
IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED UPON INFLATION AT THE TARGET LESION. THE DEVICE WAS REPLACED WITH ANOTHER CATHETER OF THE SAME SIZE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ISSUES WERE NOTED DURING DEVICE PREPARATION, AND ONLY MILD CALCIFICATION WAS PRESENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24828990 ↗MalfunctionApr 7, 2026Material Rupture
IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED UPON INFLATION AT THE TARGET SITE. A REPLACEMENT CATHETER OF THE SAME TYPE WAS THEN USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24798672 ↗MalfunctionApr 2, 2026Material Rupture
IT WAS REPORTED THAT THE SYNTEL 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 24764023 ↗MalfunctionMar 31, 2026Material Rupture
IT WAS REPORTED THAT THE SYNTEL 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 24744402 ↗MalfunctionMar 30, 2026Material Rupture
IT WAS REPORTED THAT THE SYNTEL OTW BALLOON RUPTURED DURING PRE-TESTING PRIOR TO USE IN A PROCEDURE. THE DEVICE WAS NOT USED ON THE PATIENT, AND AN ALTERNATIVE DEVICE WAS UTILIZED TO COMPLETE THE OPERATION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714910 ↗MalfunctionMar 25, 2026Material Rupture
IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE DEVICE WAS USED WITH NO ABNORMALITIES OBSERVED DURING PREPARATION. THE CATHETER WAS DIRECTLY INSERTED INTO THE ARTIFICIAL GRAFT, AND THE BALLOON WAS INFLATED WITHIN THE RECOMMENDED VOLUME RANGE. WHILE PULLING BACK THROMBUS WITH THE INFLATED BALLOON, THE BALLOON RUPTURED WITHIN THE ARTIFICIAL GRAFT. CALCIFICATION WITHIN THE GRAFT WAS DESCRIBED AS MILD. A NEW DEVICE OF THE SAME MODEL WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688301 ↗MalfunctionMar 17, 2026Material Rupture
IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED WHEN IT WAS INFLATED AT THE TARGET SITE. ANOTHER CATHETER OF THE SAME TYPE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618217 ↗MalfunctionFeb 19, 2026Material Rupture
IT WAS REPORTED THAT THE SYNTEL OTW BALLOON RUPTURED DURING A PROCEDURE. NO PATIENT INJURY WAS REPORTED. DEVICE WAS CHECKED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387609 ↗MalfunctionJan 22, 2026Material Rupture
IT WAS REPORTED THAT THE SYNTEL OTW BALLOON RUPTURED DURING BLOOD CLOT REMOVAL. DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146337 ↗MalfunctionJan 22, 2026Material Rupture
IT WAS REPORTED THAT THE SYNTEL OTW BALLOON RUPTURED DURING BLOOD CLOT REMOVAL. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146154 ↗MalfunctionJan 12, 2026Material Rupture
IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED UPON INFLATION AT THE TARGET SITE. A REPLACEMENT DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 24044911 ↗MalfunctionJan 12, 2026Material Rupture
IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED UPON INFLATION AT THE TARGET SITE. A REPLACEMENT DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 24044735 ↗MalfunctionDec 2, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT PRIOR TO PATIENT USE, A PRE-USE INSPECTION WAS PERFORMED. THE PHYSICIAN INFLATED THE BALLOON AND INJECTED NORMAL SALINE INTO THE GUIDEWIRE LUMEN, DETERMINING THE PRODUCT TO BE ACCEPTABLE BEFORE PROCEEDING WITH THE THROMBECTOMY. THE CATHETER TIP SUCCESSFULLY PASSED THROUGH THE STENOTIC LESION, AND THE BALLOON WAS INFLATED WITH THE SPECIFIED AMOUNT OF NORMAL SALINE. HOWEVER, DURING WITHDRAWAL OF THE CATHETER, THE PHYSICIAN NOTICED AN UNEXPECTED LACK OF RESISTANCE. SUBSEQUENT EXTERNAL INSPECTION, PERFORMED BY ATTEMPTING TO INFLATE THE BALLOON OUTSIDE THE BODY, CONFIRMED THAT THE BALLOON HAD RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SPARE UNIT OF THE SAME PRODUCT AVAILABLE AT THE CLINIC, WITH NO FURTHER ISSUES. NO HARM TO THE PATIENT'S HEALTH WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23701074 ↗
Other Lemaitre Vascular, Inc. products
- LeMaitre Embolectomy Catheter47 models · 438 reports · 2 recalls
- Pruitt F3 Carotid Shunt10 models · 305 reports
- Artegraft Vascular Graft15 models · 25 reports · 3 recalls
- Trivex System3 models · 69 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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