Syntel Silicone Thrombectomy Catheter A4545Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840663109807), received between Mar 3, 2023 and Aug 30, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 17, 2024Open, Classified

   The guide tip can become damaged and result in the tip detaching.

   Z-1824-2024 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionAug 30, 2023Material Separation; Material Separation

  IT WAS REPORTED SYNTEL 5F THROMBECTOMY CATHETER HAS A METAL SPRING TIP ON THE END WITH A SILICONE CAP, THIS CAP CAN BE TAKEN OFF WITH FINGERS DURING GRAFT/NATIVE FISTULA DECLOTTING PROCEDURE. WHEN INTERVENTIONIST ENCOUNTERS FRICTION, FROM THE SHEATH OR THE VESSEL WALL, THIS CAP BECOMES LOOSE, AND THE CONCERN IS THAT IT CAN END IN THE PATIENT'S LUNGS. THE SILICONE CAP WAS PLACED BACK ON THE METAL SPRING TIP. NO INJURY OCCURRED TO PATIENT. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2023-00138 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650615 ↗
• MalfunctionAug 30, 2023Material Separation; Material Separation

  IT WAS REPORTED SYNTEL 5F THROMBECTOMY CATHETER HAS A METAL SPRING TIP ON THE END WITH A SILICONE CAP, THIS CAP CAN BE TAKEN OFF WITH FINGERS DURING GRAFT/NATIVE FISTULA DECLOTTING PROCEDURE. WHEN INTERVENTIONIST ENCOUNTERS FRICTION, FROM THE SHEATH OR THE VESSEL WALL, THIS CAP BECOMES LOOSE, AND THE CONCERN IS THAT IT CAN END IN THE PATIENT'S LUNGS. THE SILICONE CAP WAS PLACED BACK ON THE METAL SPRING TIP. NO INJURY OCCURRED TO PATIENT. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2023-00137 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650614 ↗
• MalfunctionMay 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED AT THE TIME OF PERFORMING A MANEUVER IN THE PROCEDURE, THE GUIDE TIP TENDS TO DETACH IN THE AREA WHERE THE BALLOON IS LOCATED. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902474 ↗
• MalfunctionMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THREE TIP OF THE CATHETERS WERE DAMAGED DURING EXTRACTION OF THE THROMBUS. PART OF THE TIP TENDS TO DETACH. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862199 ↗
• MalfunctionMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THREE TIP OF THE CATHETERS WERE DAMAGED DURING EXTRACTION OF THE THROMBUS. PART OF THE TIP TENDS TO DETACH. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862198 ↗
• MalfunctionMar 3, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE TIP OF THE SYNTEL SILICONE THROMBECTOMY CATHETER BROKE OFF DURING THE THROMBECTOMY PROCEDURE. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477910 ↗