Scepter XC BC0411XC-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170018565), received between Nov 10, 2016 and Apr 12, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER POSITIONING A SCEPTER XC BALLOON IN THE COMMON CAROTID ARTERY, THE BALLOON DID NOT INFLATE. THE BALLOON CATHETER WAS REMOVED, AND WAS OBSERVED TO BE BROKEN INTO TWO (2) SEPARATE PIECES. ALL PORTIONS OF THE BALLOON WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6488871 ↗
• MalfunctionNov 10, 2016Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURED IN THE PATIENT. THE PHYSICIAN USED ANOTHER SCEPTER TO REPLACE THE BALLOON. THE PROCEDURE WAS SUCCESSFUL. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6092712 ↗