Syntel Silicone OTW Embolectomy Catheter A4E02Recalls & reported problems
Lemaitre Vascular, Inc. · Syntel Silicone OTW Embolectomy Catheter · Class 2
All models of Syntel Silicone OTW Embolectomy Catheter (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840663109876), received between Apr 20, 2023 and Dec 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K970762); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT WHILE REMOVING THE THROMBUS WITH THE EXPANDED BALLOON, IT RUPTURED MIDWAY. THE AMOUNT OF BALLOON INJECTED WAS WITHIN THE RECOMMENDED VOLUME. THERE WAS NO TORTUOSITY OR CALCIFICATION IN THE VESSEL. THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS USING ANOTHER CATHETER. NO INJURY WAS REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20923751 ↗MalfunctionApr 20, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON OF THE SYNTEL OVER-THE-WIRE CATHETER RUPTURED AS SOON AS THE THROMBECTOMY PROCEDURE STARTED. THERE WAS NO INJURY TO THE PATIENT. THE OPERATION WAS COMPLETED USING ANOTHER PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16776801 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K970762. One submission often covers many models, so check the product and lot details in each record.
- Z-1847-2020 · Oct 24, 2019 · TerminatedBard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10
- Z-1846-2020 · Oct 24, 2019 · TerminatedPython Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01
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
- LeMaitre Embolectomy Catheter 1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall161 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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