Syntel Silicone OTW Embolectomy Catheter A4E09Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840663109944), received between Aug 6, 2024 and May 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionAug 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SYNTEL OVER-THE-WIRE EMBOLECTOMY CATHETER BALLOON RUPTURED DURING PRE-USE CHECK. IT WAS NOT USED ON THE PATIENT AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846670 ↗
• MalfunctionJul 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SYNTEL OTW CATHETER BALLOON RUPTURED DURING A BRTO PROCEDURE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE OPERATION. THE DEVICE WAS CHECKED PRIOR TO USE. THE SURGEON SAW THE BALLOON RUPTURED THROUGH IMAGING. NO REPORT OF INJURY TO THE PATIENT. 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 22437724 ↗
• MalfunctionJul 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SYNTEL OTW CATHETER BALLOON RUPTURED DURING A BRTO PROCEDURE. THE SURGEON OVER INFLATED THE BALLOON. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE OPERATION. THE DEVICE WAS CHECKED PRIOR TO USE. THE SURGEON SAW THE BALLOON RUPTURED THROUGH IMAGING. NO REPORT OF INJURY TO THE PATIENT. 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 22437706 ↗
• MalfunctionAug 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SYNTEL OTW BALLOON RUPTURED. THEY WERE USING THE PYTHON BALLOON DURING AN OVARIAN VEIN EMBOLIZATION PROCEDURE AND UPON INFLATION THEY COULDN'T SEE ANY CONTRAST EVEN THOUGH THEY PUT SOME IN THE SYRINGE. DR. BABCOCK ASPIRATED THE BALLOON AND NOTICED IT HAD RUPTURED. THIS HAPPENED WITH TWO OF THE PYTHON BALLOONS. NO MORE THAN 2CC WAS INFLATED. THEY CHECKED THE INTEGRITY OF THE SECOND BALLOON (BOTH DEVICES PRE-CHECKED) BEFORE PLACING INSIDE THE PATIENT. IT WAS FINE UNTIL INFLATED INSIDE THE PATIENT, IT RUPTURED AGAIN. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2024-00135 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918710 ↗
• MalfunctionAug 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SYNTEL OTW BALLOON RUPTURED. THEY WERE USING THE PYTHON BALLOON DURING AN OVARIAN VEIN EMBOLIZATION PROCEDURE AND UPON INFLATION THEY COULDN'T SEE ANY CONTRAST EVEN THOUGH THEY PUT SOME IN THE SYRINGE. DR. BABCOCK ASPIRATED THE BALLOON AND NOTICED IT HAD RUPTURED. THIS HAPPENED WITH TWO OF THE PYTHON BALLOONS. NO MORE THAN 2CC WAS INFLATED. THEY CHECKED THE INTEGRITY OF THE SECOND BALLOON (BOTH DEVICES PRE-CHECKED) BEFORE PLACING INSIDE THE PATIENT. IT WAS FINE UNTIL INFLATED INSIDE THE PATIENT, IT RUPTURED AGAIN. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2024-00147 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918673 ↗

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-1846-2020 · Oct 24, 2019 · Terminated
  Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01
• Z-1847-2020 · Oct 24, 2019 · Terminated
  Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10