Scepter XC BC0411XC-IDRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00842636020591), received between Aug 18, 2017 and Aug 21, 2020 — classified as 3 deaths, 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SCEPTER WAS PREPARED PER STANDARD PROTOCOL OUTSIDE THE PATIENT AND WAS NOTED TO BE "INTACT." DURING TREATMENT IN THE PATIENT, THE BALLOON LEAKED. THERE WAS NO REPORTED PATIENT INJURY. THE CURRENT CONDITION OF THE PATIENT IS REPORTED TO BE "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10439488 ↗
• DeathJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON-ASSISTED COIL EMBOLIZATION WAS ATTEMPTED FOR AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM. UPON INFLATION OF THE BALLOON AFTER PLACEMENT AT THE TREATMENT SITE, FLUOROSCOPIC IMAGING DEMONSTRATED THE BALLOON PROTRUDING OUTSIDE THE ICA. EXTRAVASATION WAS OBSERVED. TAMPONADE COULD NOT BE COMPLETELY ACHIEVED WITH THE BALLOON; THEREFORE, TWO FLOW DIVERTERS WERE IMPLANTED, WHICH STOPPED THE BLEEDING, AND AN EXTERNAL VENTRICULAR DRAIN WAS PLACED. THE PATIENT DIED FOUR (4) DAYS AFTER THE PROCEDURE. THE INFORMATION AVAILABLE INDICATES THE EVENT WAS A RARE, BUT WELL RECOGNIZED COMPLICATION ASSOCIATED WITH THIS TYPE OF PROCEDURE.

  Patient problems: Death; Hemorrhage, Cerebral; Rupture

  MAUDE report 10324005 ↗
• MalfunctionJul 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE USING THE BALLOON TO ASSIST IN COIL EMBOLIZATION OF AN ANEURYSM, THE BALLOON SUDDENLY DEFLATED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10318042 ↗
• MalfunctionApr 17, 2020Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN INTERNAL CAROTID ARTERY ANEURYSM. A (NON-MICROVENTION) FLOW-DIVERTER STENT WAS DEPLOYED, BUT IT DID NOT OPEN PROXIMALLY. DURING AN IN-STENT INFLATION WITH THE SCEPTER BALLOON TO IMPROVE THE WALL APPOSITION, THE BALLOON RUPTURED. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9975077 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A LEFT, BI-LOBED CAROTID T ANEURYSM USING A KISSING BALLOON TECHNIQUE WITH A SCEPTER XC BALLOON AND ANOTHER COMPANY'S BALLOON. THE TRACKABILITY OF THE SCEPTER BALLOON OVER THE TRAXCESS GUIDE WIRE AROUND VESSEL CURVES WAS POOR AND THERE WAS A LOT OF FRICTION. DURING MANIPULATION OF THE DEVICES, A DISTAL VESSEL PERFORATION OCCURRED IN THE PERICALLOSAL ARTERY. BLEEDING WAS CONTROLLED BY AN INFLATION WITH THE OTHER COMPANY'S BALLOON. THE PATIENT STILL HAS A SLIGHT HEMIPARESIS THAT IS IMPROVING AND A WEAKNESS OF "A BRANCH" OF THE MOUTH. THE PATIENT IS RECOVERING SLOWLY AND PLANS WERE BEING MADE TO DISCHARGE THE PATIENT FROM THE HOSPITAL.

  Patient problems: Paresis; Perforation of Vessels

  MAUDE report 9925460 ↗
• InjuryNov 21, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING TREATMENT OF A FISTULA IN THE RIGHT POSTERIOR FOSSA, THE ONYX LIQUID EMBOLIC WAS DELIVERED AND THE TIP OF THE SCEPTER XC BALLOON BECAME STUCK IN THE ONYX. THE SCEPTER BROKE IN THE MIDDLE OF THE CATHETER IN THE AORTA DURING THE ATTEMPT TO REMOVE THE SCEPTER. THE DISTAL HALF OF THE SCEPTER REMAINED IN THE PATIENT. ASPIRIN 325 MG WAS PRESCRIBED FOR THE PATIENT (DURATION UNKNOWN). NO ADDITIONAL INTERVENTION WAS PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9360110 ↗
• MalfunctionJul 31, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN INTRACRANIAL ANEURYSM, THE BALLOON RUPTURED INSIDE OF THE PATIENT UPON THE FIRST INFLATION ATTEMPT. THERE WAS NO REPORTED INTERVENTION, PATIENT INJURY, OR HEALTH DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848486 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON DEFLATED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714544 ↗
• DeathMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ELECTIVE CASE TREATMENT OF AN UNRUPTURED ANTERIOR COMMUNICATING ANEURYSM (ACOM), AN EMBOLIZATION COIL CONTINUED TO HERNIATE OUT OF THE ANEURYSM, AND THE PHYSICIAN CHOSE TO USE A SCEPTER XC BALLOON TO ASSIST. THE COIL WAS REMOVED AND A SMALLER COIL WAS USED, AND INFLATED THE SCEPTER XC BALLOON TO MATCH THE ACOM SIZE. SEVERAL ATTEMPTS WERE MADE TO GET THE DEPLOYED COIL TO STAY IN THE ANEURYSM. A MEDTRONIC REP INSTRUCTED THE PHYSICIAN TO INFLATE THE BALLOON WHILE REMOVING THE 45° ANGLED ECHELON 10 MICROCATHETER. DURING REMOVAL OF THE ECHELON 10, THE MICROCATHETER PERFORATED THE ANEURYSM. INTRACRANIAL BLEED ENSUED, AND THE PHYSICIAN SACRIFICED THE A1 IN AN ATTEMPT TO SAVE THE PATIENT. SIX (6) COILS WERE TO SACRIFICE THE A1, AND STOPPED THE BLEEDING. AN EXTERNAL VENTRICULAR DRAIN WAS PLACED AND THE PATIENT WAS FOLLOWED FOR A FEW DAYS; HOWEVER, WAS REPORTED TO HAVE DIED OVER THE WEEKEND. THE PHYSICIAN DID NOT MAKE ANY SUGGESTIONS OF DEVICE FAILURE FOR MEDTRONIC OR MICROVENTION DEVICES USED FOR THE PROCEDURE.

  Patient problems: Death; Hemorrhage, Cerebral; Neurological Deficit/Dysfunction; Perforation of Vessels

  MAUDE report 8579850 ↗
• MalfunctionSep 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON "RUPTURED" AFTER BEING INFLATED ONCE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885998 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SCEPTER BALLOON WAS INFLATED A FIRST TIME WITHOUT ANY ISSUE AND GOOD VISIBILITY; HOWEVER, VISIBILITY OF THE BALLOON WAS LOST DURING THE 2ND INFLATION, SO CONTROL OF THE PRESSURE WAS DONE WITH A SYRINGE. DURING THIS INFLATION, A RUPTURE OF THE ARTERY OCCURRED, RESULTING IN AN INTRACEREBRAL HEMORRHAGE. THE PHYSICIAN DID NOT OBSERVE A DEVICE MALFUNCTION AND DOES NOT KNOW THE REASON FOR THE ARTERY RUPTURE. THE PATIENT'S OUTCOME AFTER THE PROCEDURE WAS REPORTED TO BE POOR. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Hemorrhage, Cerebral; Perforation of Vessels

  MAUDE report 7310960 ↗
• DeathSep 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN ANEURYSM WITH A 3MM NECK NEAR THE A1-A2 JUNCTION. THE SCEPTER XC BALLOON WAS PREPPED SUCCESSFULLY WITHOUT ISSUES. AFTER DEPLOYMENT OF THE FIRST COIL, THE BALLOON WAS POSITIONED ON THE A1-A2 JUNCTION OPPOSITE THE NECK OF THE ANEURYSM. DURING THE FIRST INFLATION, THE BALLOON WAS NOT VISIBLE, SO THE BALLOON WAS DEFLATED AND THE SYRINGE WAS EXCHANGED FOR THE SAME SYRINGE WITH A 50% CONTRAST/50% SALINE MIXTURE USED FOR PREPARATION. THE BALLOON WAS THEN RE-INFLATED AND WAS VISIBLE. A SECOND COIL WAS DEPLOYED AND THE BALLOON WAS DEFLATED UNDER FLUOROSCOPY. A RUPTURE OF THE ARTERY AND DISSECTION IN THE VESSEL WAS THEN IDENTIFIED AT THE SITE OF THE BALLOON INFLATION. THE BALLOON WAS REPOSITIONED DOWNSTREAM OF THE RUPTURE TO PREVENT BLEEDING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE FOR A FEW MINUTES BEFORE THE VITALS SIGNS DROPPED. THE PATIENT WAS CLOSELY MONITORED BY THE ANESTHETIST TEAM OVER "SEVERAL TENS OF MINUTES" AND THE HEMORRHAGE WAS REPORTED TO HAVE STOPPED. AN MRI WAS PERFORMED TO EVALUATE THE CONSEQUENCES OF THE INCIDENT. THE DAY AFTER THE PROCEDURE, THE PATIENT DIED.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Rupture; Vascular Dissection

  MAUDE report 6903172 ↗
• MalfunctionAug 18, 2017Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS IDENTIFIED THAT TWO SCEPTER XC BALLOONS WERE INADVERTENTLY MISSED FROM THE TERMINAL STERILIZATION PROCESS AND SHIPPED TO A CUSTOMER. THE PHYSICIAN WAS IMMEDIATELY NOTIFIED. TWO SCEPTER XC BALLOONS WERE SELECTED FOR USE ON (B)(6) 2017 IN A PATIENT THAT WAS CLASSIFIED AS HH1, CLINICALLY IN GOOD CONDITION, WHO WAS UNDERGOING TREATMENT FOR A RUPTURED ANEURYSM. THE FIRST SCEPTER BALLOON WAS SELECTED FOR TREATMENT, BUT WAS NOT USED DUE TO THE PRESENCE OF A KINK ON THE SHAFT. THE SECOND SCEPTER BALLOON WAS USED IN THE PATIENT TO ASSIST WITH COIL PLACEMENT INSIDE THE ANEURYSM SAC (BALLOON REMODELING TECHNIQUE). THE DECISION WAS MADE TO ADMINISTER PROPHYLACTIC TREATMENT WITH A BROAD-SPECTRUM ANTIBIOTIC (TAZOBAC) POST-PROCEDURE. CURRENTLY, THE PATIENT DOES NOT EXHIBIT SIGNS OF INFECTION; THERE IS NO ELEVATION OF CRP OR LEUKOCYTES. THE PATIENT IS BEING CLOSELY MONITORED BY THE PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803005 ↗
• MalfunctionAug 18, 2017Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS IDENTIFIED THAT A SCEPTER XC BALLOON WAS INADVERTENTLY MISSED FROM THE TERMINAL STERILIZATION PROCESS AND SHIPPED TO A CUSTOMER. THE PHYSICIAN WAS IMMEDIATELY NOTIFIED. THE BALLOON WAS USED IN A PATIENT THAT WAS CLASSIFIED AS HH4 (HUNT AND HESS SCALE) WHO WAS UNDERGOING TREATMENT FOR A RUPTURED ANEURYSM. THE BALLOON WAS FIRST USED TO PLACE COILS INSIDE THE ANEURYSM SAC (BALLOON REMODELING TECHNIQUE) AND THEN TO DELIVER AN ACCLINO FLEX STENT AT THE NECK OF THE ANEURYSM. THE PATIENT WAS BEING TREATED WITH A BROAD-SPECTRUM ANTIBIOTIC (TAZOBAC) FOR PNEUMONIA PRIOR TO PROCEDURE. CURRENTLY, THE PATIENT IS STILL INTUBATED. THE PATIENT IS BEING CLOSELY MONITORED BY THE PHYSICIAN, NO ADDITIONAL COMPLICATIONS OR CHANGES IN BLOOD COUNT OBSERVED AT THIS POINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803002 ↗
• MalfunctionAug 18, 2017Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS IDENTIFIED THAT TWO SCEPTER XC BALLOONS WERE INADVERTENTLY MISSED FROM THE TERMINAL STERILIZATION PROCESS AND SHIPPED TO A CUSTOMER. THE PHYSICIAN WAS IMMEDIATELY NOTIFIED. TWO SCEPTER XC BALLOONS WERE SELECTED FOR USE ON (B)(6) 2017 IN A PATIENT THAT WAS CLASSIFIED AS HH1, CLINICALLY IN GOOD CONDITION, WHO WAS UNDERGOING TREATMENT FOR A RUPTURED ANEURYSM. THE FIRST SCEPTER BALLOON WAS SELECTED FOR TREATMENT, BUT WAS NOT USED DUE TO THE PRESENCE OF A KINK ON THE SHAFT. THE SECOND SCEPTER BALLOON WAS USED IN THE PATIENT TO ASSIST WITH COIL PLACEMENT INSIDE THE ANEURYSM SAC (BALLOON REMODELING TECHNIQUE). THE DECISION WAS MADE TO ADMINISTER PROPHYLACTIC TREATMENT WITH A BROAD-SPECTRUM ANTIBIOTIC (TAZOBAC) POST-PROCEDURE. CURRENTLY, THE PATIENT DOES NOT EXHIBIT SIGNS OF INFECTION; THERE IS NO ELEVATION OF CRP OR LEUKOCYTES. THE PATIENT IS BEING CLOSELY MONITORED BY THE PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803001 ↗