Syntel Silicone OTW Embolectomy Catheter A4E04Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840663109890), received between Mar 27, 2024 and Sep 29, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 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 50936038 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE THE BALLOON WAS BEING INFLATED AT THE TARGET SITE IN THE VESSEL TO REMOVE A CLOT, IT RUPTURED. A NEW DEVICE WAS PREPARED AS A REPLACEMENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO INJURY REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894315 ↗
• MalfunctionFeb 19, 2025Material Rupture; Material Rupture

  WHEN INFLATING THE BALLOON IN THE DIALYSIS SHUNT, IT RUPTURED BEFORE PRESSURE WAS APPLIED TO THE BALLOON. DUE TO CONSECUTIVE BALLOON RUPTURES, THE PROCEDURE WAS COMPLETED USING A FOGARTY CATHETER. NO INJURY WAS REPORTED 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 21411222 ↗
• MalfunctionFeb 19, 2025Material Rupture; Material Rupture

  WHEN INFLATING THE BALLOON IN THE DIALYSIS SHUNT, IT RUPTURED BEFORE PRESSURE WAS APPLIED TO THE BALLOON. DUE TO CONSECUTIVE BALLOON RUPTURES, THE PROCEDURE WAS COMPLETED USING A FOGARTY CATHETER. NO INJURY WAS REPORTED 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 21411209 ↗
• MalfunctionJul 10, 2024Material Rupture; Material Rupture

  THE BALLOON RUPTURED IN THE VESSEL DURING THROMBUS RETRIEVAL. A SECOND OVER-THE-WIRE THROMBECTOMY CATHETER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE ARE NO PROBLEMS WITH THE PATIENT'S HEALTH STATUS. THERE ARE NO PROBLEMS WITH STORAGE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709339 ↗
• InjuryJun 19, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE SYNTEL OTW HAS A PIN HOLE AT HUB OF WORKING END AND BLOOD WAS SQUIRTTING OUT. A NEW CATHETER WAS USED. PATIENT WAS BLEEDING AND ON THE TABLE LONGER THAN EXPECTED. NO FURTHER COMPLICATIONS OR INJURY WAS REPORTED. PATIENT WAS DOING FINE AFTER THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19565828 ↗
• InjuryMar 27, 2024Material Rupture; Material Perforation; Material Rupture; Material Perforation

  ACCORDING TO A SURVEY, IT WAS REPORTED THE BALLOON RUPTURED DURING A PROCEDURE. ADDITIONALLY, THEY REPORTED BLOOD LOSS OF 2000ML; HOWEVER, IT WAS NOT CRITICAL AND NOT DIRECTLY FROM USE OF THE DEVICE. ALSO, HIGHER PERFORATION COMPARED TO A NORMAL FOGARTY CATHETER. THE BALLOON RUPTURE DID NOT PROLONG THE PROCEDURE. THE DOCTOR DOES NOT BELIEVE IT WAS A PRODUCT ISSUE. THEIR MAIN ISSUE IS THAT THEY OPERATE OFTEN NOT IN A NORMAL HUMAN AREA OR ANATOMY. OFTEN THE PATIENTS ARE PRE-OPERATED AND TREATED ENDOVASCULAR WITH STENTS AND IN AREAS OF CALCIFICATION. OFTEN, IT'S HARD TO NAVIGATE IN THESE MANIPULATED AREAS. SO, IT WAS NOT A BIG CONCERN THAT THE BALLOON RUPTURED. THEY ARE CONSIDERING TUFTEX OTW IN THE FUTURE, AS THE BALLOON HAS MORE STRENGTH. NO OTHER COMPLICATIONS OR INJURY WERE REPORTED TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18986739 ↗
• InjuryMar 27, 2024Material Rupture; Material Rupture

  THE INITIAL REPORT INDICATED THAT A PRODUCT FAILURE OCCURRED FOR 4 DIFFERENT EVENTS. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ONLY 1 OCCURRENCE OF THE REPORTED FAILURE OCCURRED AND THE ADDITIONAL REPORTS WERE DUPLICATES. THE INITIAL REPORT FOR THIS CASE WAS FILED AS A DUPLICATE SUBMISSION AND IS NO LONGER CONSIDERED AN INCIDENT. THE SINGLE REPORTED INCIDENT IS DOCUMENTED IN REPORT 1220948-2024-00073.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18986735 ↗

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