Scepter C BC0415C-IDRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842636020546), received between Apr 23, 2019 and Aug 26, 2024 — classified as 8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Material Rupture; Material Rupture

  AS REPORTED: INTRAOPERATIVE PRESSURE TO 0.30CC, THE BALLOON BURST IN THE RATED RANGE. THE PROCEDURE WAS COMPLETED AFTER THE SAME TYPE OF BALLOON WAS REPLACED. IT WAS A SUDDEN LOSS OF PRESSURE WHEN THE BALLOON BURST. PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072029 ↗
• MalfunctionFeb 26, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT CORRECTLY DEFLATE DURING THE PROCEDURE. THE BALLOON WAS REMOVED WHILE MOSTLY INFLATED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11389405 ↗
• MalfunctionDec 23, 2020Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED DURING THE PROCEDURE. THE BALLOON WAS REMOVED THROUGH THE INTERMEDIATE CATHETER WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11069631 ↗
• MalfunctionNov 21, 2019Failure to Fold; Failure to Fold

  IT WAS REPORTED THAT DURING BALLOON-ASSISTED COILING OF AN INTERNAL CAROTID ARTERY ANEURYSM, THE BALLOON WAS NOT DEFLATING RAPIDLY AFTER INFLATING AND DEFLATING 2-3 TIMES. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9359987 ↗
• MalfunctionJul 31, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED IN THE PATIENT DURING THE PROCEDURE. THERE WAS NO REPORTED INTERVENTION, PATIENT INJURY, OR HEALTH DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848532 ↗
• MalfunctionJul 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON SUDDENLY DEFLATED IN THE PATIENT DURING THE PROCEDURE. THERE WAS NO REPORTED INTERVENTION, PATIENT INJURY, OR HEALTH DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823770 ↗
• MalfunctionMay 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SCEPTER C BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616697 ↗
• MalfunctionApr 23, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A STENT WAS IMPLANTED IN THE INTERNAL CAROTID ARTERY AND THE SCEPTER BALLOON WAS INFLATED TO POST-DILATE THE STENT; HOWEVER, THE BALLOON COULD NOT BE DEFLATED. ATTEMPTS TO DEFLATE THE BALLOON WITH A 3ML AND A 20ML SYRINGE WERE UNSUCCESSFUL AND THE INFLATED BALLOON WAS REMOVED THROUGH THE STENT. THERE WAS NO MOVEMENT OF THE STENT FROM ITS IMPLANTED POSITION DURING THE BALLOON RETRACTION. THERE WAS NO REPORTED PATIENT INJURY OR PROCEDURAL CLINICAL CONSEQUENCE, AND NO INTRA-PROCEDURAL MEDICATIONS WERE GIVEN TO THE PATIENT OUTSIDE OF NORMAL PROCEDURE PROTOCOL AT THE TIME OF THE EVENT OR POST-PROCEDURE. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541751 ↗