Balloon Catheter BC0410C-ID-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00842429103388), received between May 13, 2021 and Mar 20, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN ONYX EMBOLIZATION TREATMENT IN THE LEFT OPHTHALMIC ARTERY TO TREAT A TUMOR. WHEN THE EMBOLIZATION PROCEDURE WAS OVER, THE PHYSICIAN TRIED TO REMOVE THE BALLOON. ONYX WAS ADHERED TO BALLOON AND THE BALLOON CATHETER DID NOT WANT TO COME OUT. THE BALLOON CATHETER BROKE, AND SOME OF THE BALLOON CATHETER REMAINED IN THE GUIDE CATHETER AND BLOOD VESSEL. THE PHYSICIAN USED A TREVO DEVICE TO REMOVE A LARGE SEGMENT OF THE BALLOON CATHETER THAT REMAINED. THERE WAS STILL A FRAGMENT OF THE BALLOON CATHETER THAT REMAINED IN THE BODY. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18946753 ↗
• MalfunctionDec 19, 2023Break; Break

  NO ADDITIONAL INFORMATION RECEIVED. THIS REPORT REPRESENTS CORRECTIONS TO A PREVIOUSLY SUBMITTED MDR. FIELDS CORRECTED ARE LISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360150 ↗
• MalfunctionMay 18, 2023Material Rupture; Material Rupture

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959285 ↗
• MalfunctionMar 29, 2023Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  PLEASE SEE SECTION H10 FOR DEVICE INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640427 ↗
• MalfunctionFeb 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS PREPARED PROPERLY AND BURST UPON INFLATION DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING OTHER PRODUCT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376613 ↗
• MalfunctionJun 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A SCEPTER BALLOON CATHETER BURST DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860504 ↗
• MalfunctionJun 2, 2022Deflation Problem; Deflation Problem

  DURING THE PROCEDURE, A SCEPTER BALLOON WAS USED TO ANGIOPLASTY A PIPLELINE SHIELD THAT WOULD NOT OPEN. AFTER INFLATING THE BALLOON, IT WOULD NOT DEFLATE. THE BALLOON WAS REMOVED FROM THE PATIENT PARTIALLY INFLATED. THERE WAS NO PATIENT INJURY OR INTERVENTION REPORTED. PATIENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED STATING THE BALLOON WAS OBSERVED TO BE NORMAL DURING PREPARATION. THE INFLATION PRESSURE OF THE BALLOON IS UNKNOWN. THE BALLOON WAS PARTIALLY DEFLATED BY ASPIRATION WITH 1CC SYRINGE. THE DEVICE WAS REMOVED BY ASPIRATION AND RETRIEVAL THROUGH THE WAHOO GUIDE CATHETER. THERE WAS BLOOD INSIDE THE BALLOON LUMEN ONCE IT WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14579841 ↗
• MalfunctionMay 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, A SCEPTER C BALLOON RUPTURED DURING INFLATION. THERE WAS NO REPORTED INTERVENTION OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401772 ↗
• MalfunctionSep 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE, A SCEPTER C BALLOON RUPTURED DURING INJECTION OF CONTRAST MEDIUM. THERE WAS NO REPORTED INTERVENTION OR INJURY TO THE PATIENT. THE PATEINT'S CONDITION IS REPORTED TO BE "NORMAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510859 ↗
• MalfunctionSep 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE, A SCEPTER BALLOON RUPTURED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443543 ↗
• MalfunctionSep 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE, A SCEPTER BALLOON RUPTURED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443260 ↗
• MalfunctionMay 13, 2021Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A BALLOON CATHETER DID NOT DEFLATE DURING USE. IT WAS REMOVED WITHOUT INJURY TO THE PATIENT OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822502 ↗