Syntel Silicone OTW Embolectomy Catheter A4E06Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00840663109913), received between Oct 28, 2022 and Apr 2, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SYNTEL OVER-THE-WIRE CATHETER BALLOON RUPTURED DURING PATIENT USE. THE DEVICE HAD BEEN CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003514 ↗
• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SYNTEL OVER-THE-WIRE CATHETER BALLOON RUPTURED DURING PATIENT USE. THE DEVICE HAD BEEN CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003497 ↗
• InjuryMar 27, 2024Material Rupture; Material Perforation; Material Rupture; Material Perforation

  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 18986725 ↗
• 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 18986719 ↗
• MalfunctionNov 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE HOSPITAL RECENTLY PURCHASED THESE CATHETERS FOR THE FIRST TIME. THE COORDINATOR STATED THAT DURING THE FIRST CASE THE BALLOON RUPTURED RIGHT AWAY BEFORE BEING FULLY INFLATED DURING A UPPER EXTREMITY FISTULA THROMBECTOMY PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175816 ↗
• MalfunctionApr 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOONS OF FOUR SYNTEL OVER-THE-WIRE EMBOLECTOMY CATHETERS RUPTURED DURING A THROMBECTOMY PROCEDURE. THE DEVICE WAS DEFLATED AND PULLED THROUGH THE ARTERY ON DIALYSIS TO REMOVE A BLOOD CLOT WHEN THE ISSUE OCCURRED. NO INJURY OCCURRED. PLEASE NOTE THAT THIS IS REPORT 1 OF 4. REPORTS 1220948-2023-00060, 1220948-2023-00061, AND 1220948-2023-00062 WERE SUBMITTED FOR THE REMAINING 3 DEVICES RELATED TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765615 ↗
• MalfunctionOct 28, 2022Material Rupture; Material Rupture

  AFTER PERFORMING THE BALLOON CHECK BEFORE USE, THE CATHETER WAS INSERTED FROM THE LEFT SUBCLAVIAN ARTERY VIA THE SHEATH. THE CATHETER WAS ADVANCED FROM THE LEFT SUBCLAVIAN ARTERY TO NEAR THE CONFLUENCE OF THE AORTIC ARCH. THE BALLOON WAS INFLATED USING THE ATTACHED SYRINGE, AND IT WAS CONFIRMED THAT THE BALLOON WAS INFLATED NORMALLY. HOWEVER, IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE BALLOON BECAME SMALLER BEFORE THE BALLOON WAS DEFLATED. WHEN THE CATHETER WAS PULLED OUT AND CONFIRMED, A RUPTURE OF THE BALLOON WAS CONFIRMED. NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693837 ↗

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