Balloon Catheter BC0411XC-ID-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00842429103418), received between Nov 1, 2021 and Apr 18, 2024 — classified as 2 deaths, 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE DOCTOR OBSERVED DEBRIS FLOATING IN THE SCEPTER XC BALLOON DURING DEVICE PREPARATION. THIS WAS REALIZED DURING INJECTION OF CONTRAST SOLUTION THROUGH BALLOON INFLATION PORT. THE DEVICE WAS NOT USED AND WAS DISCARDED, A NEW SCEPTER XC WAS SELECTED. THE DEVICE WAS NOT USED IN PATIENT; NO NEGATIVE OUTCOME CAUSED BY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134009 ↗
• MalfunctionApr 15, 2024Gas/Air Leak; Gas/Air Leak

  PLEASE SEE SECTION H11 FOR DEVICE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111616 ↗
• MalfunctionJan 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499918 ↗
• DeathNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS PATIENT DEATH SUBSEQUENT TO A PROCEDURE WHERE THE COMPANY WAS ADVISED THE PHYSICIAN HAD USED A SCEPTER XC BALLOON CATHETER. ACCORDING TO THE REPORT, DURING AN ELECTIVE FLOW DIVERTER AND COILING PROCEDURE TO TREAT A PATIENT WITH UNRUPTURED MCA ANEURYSM, THE PHYSICIAN DEPLOYED A COMPETITOR'S FLOW DIVERTER STENT WITH INTENSION TO LAND IN PROXIMAL M1 SEGMENT OF THE MCA. IN THE FIRST PARTIAL DEPLOYMENT OF THE COMPETITOR¿S PRODUCT, THE STENT APPEARED AS IF IT WOULD LAND TOO CLOSE TO THE ANEURYSM NECK. THE PHYSICIAN RE-SHEATHED THE COMPETITOR¿S STENT AND RE-DEPLOYED IT AT AN APPROPRIATE POSITION AT THE ORIGIN OF THE M1. HOWEVER, ACCORDING TO THE REPORT, THE STENT IMMEDIATELY FORESHORTENED DRAMATICALLY AND PROLAPSED PARTIALLY AT ITS PROXIMAL END IN THE ANEURYSM. THE PHYSICIAN DEPLOYED A COIL IN THE ANEURYSM TO ATTEMPT TO CORRECT THE POSITION OF THE COMPETITOR¿S STENT BUT THIS DID NOT PUSH THE STENT OUT. ACCORDING TO THE REPORT, THE PHYSICIAN DECIDED TO STRAIGHTEN OUT THE STENT BY DEPLOYING ANOTHER DIFFERENT MODEL 4X24 STENT WITHIN THE FLOW DIVERTING STENT IN AN ATTEMPT TO STRAIGHTEN IT OUT IN THE MAIN VESSEL AND ANCHOR IT TO PREVENT IT FROM FLOPPING INTO THE ANEUR

  Patient problems: Ruptured Aneurysm

  MAUDE report 18188351 ↗
• MalfunctionJul 12, 2023Contamination; Contamination

  IT WAS REPORTED THAT DURING PREPARATION, A FOREIGN SUBSTANCE WAS NOTICED AT THE TIP OF THE SCEPTER BALLOON. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313393 ↗
• InjuryApr 25, 2023Air/Gas in Device; Air/Gas in Device

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811762 ↗
• MalfunctionFeb 9, 2023Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THE PHYSICIAN WAS TREATING AN ACOM ANEURYSM ON THE LEFT AND A COIL EMBOLIZATION IN REMODELING TECHNIQUE WAS PLANNED. REPORTEDLY, DURING THE FIRST INFLATION INSIDE THE PATIENT THE SCEPTER XC BALLOON RUPTURED DISTALLY AND CONTRAST LEAKED OUT OF THE TIP. THE BALLOON WAS REMOVED COMPLETELY FROM THE PATIENT BODY. NO FRAGMENTS WERE LEFT IN THE PATIENT. A A NEW BALLOON WAS EXCHANGED AND THE CASE CONTINUED AND COMPLETED SUCCESSFULLY. NO INJURY CAUSED BY THIS ISSUE AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16343484 ↗
• MalfunctionNov 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING TREATMENT USING A SCEPTER XC BALLOON, THE BALLOON INITIALLY HAD DIFFICULTY PRIMING DURING SET UP. WHEN THE BALLOON WAS INFLATED INSIDE THE PATIENT, IT RUPTURED. NO PATIENT INJURY OR ADVERSE REACTIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756862 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING TREATMENT OF AN EMBOLIZATION OF A ARTERIOVENOUS MALFORMATION (AVM) AND CONGESTIVE CARDIAC FAILURE (CCF) WITH A SCEPTER BALLOON, MULTIPLE COILS AND A COMPETITOR'S LIQUID EMBOLIC SYSTEM, THE EMBOLIC SYRINGE BROKE OFF AT THE HUB OF THE SCEPTER XC BALLOON CATHETER. THE MICROCATHETER AND BALLOON WERE REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO HAVE A STROKE DURING THE PROCEDURE AND THE PHYSICIAN EMBOLIZED OTHER FEEDING VESSELS.

  Patient problems: Stroke/CVA

  MAUDE report 15089892 ↗
• MalfunctionMar 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A SCEPTER XC BALLOON CATHETER BURST DURING THE PROCEDURE. IT WAS REMOVED AND REPLACED WITH ANOTHER BALLOON CATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13805913 ↗
• MalfunctionJan 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING TREATMENT USING A SCEPTER XC BALLOON, THE BALLOON BURST USING 70:30 CONTRAST MIX UPON DEPLOYMENT OF A GUIDEWIRE. NO COMPLICATIONS OR ADVERSE CLINICAL CONSEQUENCE WERE REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170728 ↗
• DeathDec 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SCEPTER XC BALLOON WAS USED DURING TREATMENT OF TWO UNRUPTURED ANEURYSMS OF THE RIGHT MIDDLE CEREBRAL ARTERY. THE FIRST ANEURYSM WAS TREATED WITHOUT INCIDENT. DURING TREATMENT OF THE SECOND ANEURYSM, THE ANATOMICAL CONFIGURATION OF THE PATIENT VESSEL INHIBITED THE INFLATED BALLOON FROM PROTRUDING FULLY INTO THE ANEURYSM SAC. DURING BALLOON INFLATION, THE PORTAL ARTERY RUPTURED CAUSING A SEVERE CEREBRAL HEMORRHAGE. HEMOSTASIS WAS ATTEMPTED BY INFLATING THE BALLOON IN THE CAROTID ENDINGS, BUT WAS NOT SUCCESSFUL. THE SURGEON THEN ATTEMPTED TO STOP THE HEMORRHAGE BY OCCLUDING THE MIDDLE CEREBRAL ARTERY WITH COILS, BUT THE PATIENT SUFFERED A STROKE AND PASSED AWAY SHORTLY THEREAFTER.

  Patient problems: Hemorrhagic Stroke; Rupture

  MAUDE report 13049228 ↗
• MalfunctionNov 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED DURING USE IN A PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT, WHO WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12733264 ↗