Balloon Catheter BC0415C-ID-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842429103395), received between Jan 13, 2021 and Jul 3, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 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.

• MalfunctionJul 3, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A SCEPTER BALLOON CATHETER DID NOT DEFLATE DURING A COIL EMBOLIZATION PROCEDURE. THE DEVICE WAS REMOVED IN AN INFLATED STATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THE PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662926 ↗
• MalfunctionMay 9, 2024Material Rupture; Material Rupture

  AS REPORTED: DURING THE BALLOON-ASSISTED-COILING OF A MEDIA ANEURYSM, THE BALLOON BURST WITHIN THE VESSEL. THE BALLOON WASN'T INFLATED COMPLETELY ¿ AROUND 50-70%. WHEN THE BALLOON HAD BURST, THERE WAS A QUICK LOSS OF VOLUME IN A SHORT TIME. THE EVENT HAD NO INFLUENCE ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280646 ↗
• MalfunctionApr 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING ATTEMPT TO INFLATE THE SCEPTER BALLOON INSIDE TARGET VESSEL (ICA) UNDER FLUOROSCOPY, THE BALLOON DID NOT APPEAR TO INFLATE AND WAS REMOVED FROM THE PATIENT, WHERE IT WAS FOUND TO HAVE RUPTURED. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13983878 ↗
• MalfunctionMar 26, 2022Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT THE SCEPTER BALLOON EXHIBITED A RAPID PRESSURE LOSS AND CONTRAST LEAKAGE DURING AN OCCLUSION TEST PRIOR TO A CAROTID OCCLUSION. THERE WAS NO PATIENT HARM REPORTED. THE PATIENT IS RELEASED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13923624 ↗
• MalfunctionAug 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING BALLOON INFLATION WITHIN A FLOW DIVERTER STENT, THE BALLOON RAPIDLY LOST PRESSURE. THE BALLOON CATHETER WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298386 ↗
• MalfunctionJan 13, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT CORRECTLY DEFLATE DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168473 ↗