SCEPTER BC0410C-ID-700-ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429117545), received between Jul 22, 2024 and Mar 17, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Material Deformation

  AS REPORTED: SCEPTER BALLOON WASN'T OPENING PROPERLY (SHAPE ISSUE). HYDROSOFT COIL DIDN'T DETACH. THE PATIENT WAS REPORTED TO BE OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621560 ↗
• InjuryApr 24, 2025Gas/Air Leak; Air/Gas in Device; Gas/Air Leak; Air/Gas in Device

  NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT DESCRIPTION.

  Patient problems: Air Embolism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904029 ↗
• MalfunctionJan 17, 2025Material Rupture; Failure to Deflate; Material Rupture; Failure to Deflate

  AS REPORTED, DURING A FLOW DIVERSION WITH PIPELINE. THE STENT WOULD NOT OPEN SO THEY ANGIO-PLASTIED WITH A SCEPTER. AFTER THEY INFLATED TO OPEN THE STENT, THE SCEPTER WOULD NOT DEFLATE. MULTIPLE SYRINGES WERE TRIED AND WOULD NOT DEFLATE. THE PHYSICIAN HAD TO PULL THE SCEPTER WHILE INFLATED AND PULLED WITHIN THE GUIDE CATHETER MAKING IT POP TO GET INSIDE. THE CASE WAS COMPLETED PER USUAL PROTOCOL. ANGIO-PLASTIED THE STENT AND REMOVED THE SCEPTER INFLATED THROUGH THE GUIDE CATHETER. NO INTERVENTION PERFORMED. THE PATIENT IS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186043 ↗
• MalfunctionJul 24, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING USE IN AN UNSPECIFIED EMBOLIZATION PROCEDURE, THE BALLOON CATHETER WOULD NOT DEFLATE. THE PHYSICIAN SLOWLY PULLED OUT THE DEVICE FROM THE PATIENT WITHOUT ANY INJURY. REPORTEDLY, DURING PREPARATION, THE BALLOON TESTED SUCCESSFULLY WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823593 ↗
• MalfunctionJul 22, 2024Material Rupture; Material Rupture

  ADDITIONAL CLARIFICATION REPORTED THAT THERE WAS A RAPID LOSS OF PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801424 ↗