Syntel Silicone OTW Embolectomy Catheter A4E05Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840663109906), received between Dec 16, 2021 and Feb 22, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionFeb 22, 2024Material Rupture; Material Rupture

  WHEN THE BALLOON WAS INFLATED AT THE VOLUME SPECIFIED IN THE PACKAGE INSERT FOR USE IN THE UPPER ARM, IT RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT PRODUCT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760160 ↗
• 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 4 OF 4. REPORTS 1220948-2023-00059, 1220948-2023-00060, AND 1220948-2023-00061 WERE SUBMITTED FOR THE REMAINING 3 DEVICES RELATED TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765697 ↗
• 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 2 OF 4. REPORTS 1220948-2023-00059, 1220948-2023-00060, 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 16765688 ↗
• 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 2 OF 4. REPORTS 1220948-2023-00059, 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 16765661 ↗
• MalfunctionFeb 23, 2022Unraveled Material; Unraveled Material

  DURING GRAFT DECLOTTING, THE LIGATURE NEAR TO THE TIP OF THE CATHETER UNRAVELED. THIS INCIDENT DID NOT CAUSE ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584297 ↗
• MalfunctionDec 16, 2021Material Rupture; Material Rupture

  THE BALLOON OF THE SYNTEL OVER-THE-WIRE EMBOLECTOMY CATHETER POPPED DURING AN EMBOLECTOMY PROCEDURE. SO, THE SURGEON USED ANOTHER CATHETER FOR THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018449 ↗

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 · Terminated
  Bard 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 · Terminated
  Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01