SCEPTER BC0411XC-ID-700-ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00842429117583), received between Apr 30, 2024 and Nov 7, 2025 — classified as 1 death, 2 injuries, 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Material Rupture; Failure to Deflate; Material Rupture; Failure to Deflate

  AS REPORTED VIA MEDWATCH # MW5176421: RUPTURED BALLOON ON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503971 ↗
• DeathNov 3, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED TO MICROVENTION THAT THE PHYSICIAN DID NOT THINK THE BALLOON FULLY DEFLATED, WHICH RESULTED IN THE PHYSICIAN FINDING IT CHALLENGING TO TRACK THE CATHETER TO THE OPTIMAL LOCATION. REPORTEDLY THE DEVICE DID NOT PUNCTURE ANY ORGAN OR TISSUE, HOWEVER IT WAS THOUGHT THE DEVICE ¿DID NOT GET TO WHERE IT NEEDED TO BE¿ BECAUSE OF THE REPORTED DEFLATION CONDITION. THERE WAS NO INTERVENTION NOTED FOR THE SURGERY PERFORMED (B)(6) 2025, HOWEVER IT IS REPORTED THE PATIENT PASSED AWAY WITHIN 24 HOURS OF THE SURGERY. REPORTEDLY, THE CAUSE OF DEATH WAS SUBARACHNOID HEMORRHAGE. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23458436 ↗
• InjuryMar 26, 2025Failure to Deliver; Adverse Event Without Identified Device or Use Problem; Failure to Deliver; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CEREBRAL EMBOLIZATION, THE DOCTOR HAD THE COMPLAINT BALLOON PREPARED UNDER IFU. HOWEVER, UPON ATTEMPTING TO INJECT ONYX THROUGH THE BALLOON, IT WAS NOT ABLE TO INJECT ANY ONYX AT ALL. EMBOLIZATION WAS ABORTED AS THE RESULT OF THAT. IT IS UNKNOWN WHY ANOTHER DEVICE WAS NOT USED TO COMPLETE THE CASE. THE PATIENT CURRENT CONDITION WAS REPORTED AS LEFT UNTREATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704294 ↗
• MalfunctionDec 11, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT: AFTER USING THE BALLOON AT THE NECK OF THE OF THE SYLVIAN ANEURYSM TO BE EMBOLIZED, THE PHYSICIAN FOUND IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON. THE SCEPTER WAS REMOVED GENTLY AND VERY SLOWLY TO AVOID ANY DAMAGE TO THE ARTERY WALL. THE PHYSICIAN USED ANOTHER SCEPTER TO PERFORM / COMPLETE THE PROCEDURE. NO ACTUAL PATIENT IMPACT OR INJURY IS DOCUMENTED, AND IT WAS CONFIRMED PATIENT OUTCOME WAS GOOD AT THE END OF THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909099 ↗
• MalfunctionNov 8, 2024Material Rupture; Material Rupture

  AS REPORTED: PATIENT UNDERGOING FURTHER EMBOLIZATION OF VERTEBROBASILAR ANEURYSM. AFTER PREPARATION OF THE BALLOON IN ACCORDANCE WITH RECOMMENDATIONS, THE BALLOON WAS FOUND TO BE POROUS AND STRIATED, AND AIR ENTRY WAS VISUALIZED WHILE BEING USED INSIDE THE PATIENT. THE PATIENT IS WELL AFTER THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED: THERE WAS NO AIR INSIDE THE BALLOON, THIS ONE WAS A LITTLE BIT STRETCHED WHEN THEY PULL IT BACK AFTER IT BROKE INSIDE THE PATIENT WITH PRODUCT OF CONTRAST AND SERUM PHYSIOLOGIC. WHEN THE BALLOON BROKE THE PHYSICIAN JUST PULL IT BACK OF THE PATIENT WITHOUT DAMAGE. THE PATIENT WENT WELL AND THEY PERFORMED THE PROCEDURE WITH ANOTHER BALLOON OF THE COMPETITORS. THE PHYSICIAN IS COMPLAINING ABOUT THE BALLON BREAKAGE WITHOUT AIR. THERE IS NO IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637512 ↗
• MalfunctionOct 29, 2024Contamination; Contamination

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559527 ↗
• MalfunctionOct 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PHYSICIAN WERE TREATING AN ANEURYSM ON THE RIGHT ICA. A COIL EMBOLIZATION IN REMODELING TECHNIQUE WAS PLANNED. A SCEPTER XC 4-11 BALLOON WAS CHOSEN FOR THE PROCEDURE. THE BALLOON WAS PREPARED AND THE TIP WAS SEALED BY USING THE HEAT GUN. THE BALLOON WAS PLACED AT THE NECK OF THE ANEURYSM. A COILING MICROCATHETER WAS PLACED INSIDE THE ANEURYSM. AFTER PLACING THE TWO COILS THE MICROCATHETER LOST ITS POSITION. THE BALLOON WAS DEFLATED AND THE COILING MICROCATHETER REPOSITIONED. WHEN THE PHYSICIAN INFLATED THE BALLOON AGAIN IT WAS ALMOST NOT VISIBLE. SHE REMOVED THE BALLOON FROM THE PATIENT AND CHECKED IT. SHE FOUND BLOOD INSIDE THE BALLOON. THE TIP WAS SEALED WITH THE HEAT GUN FOR A SECOND TIME. THE BALLOON WAS PLACED AT THE NECK OF THE ANEURYSM. DURING THE INFLATION THE DISTAL TIP OF THE BALLOON BURST. THE BALLOON WAS EXCHANGED TO A NEW PRODUCT. THE EXAMINATION WAS CONTINUED WITH GOOD RESULT. THE PATIENT IS DOING WELL. NO INJURY CAUSED BY THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501113 ↗
• MalfunctionSep 28, 2024Deflation Problem; Deflation Problem

  AS REPORTED, DURING AN M1 ANEURYSM EMBOLIZATION FOLLOWING SUBARACHNOID HEMORRHAGE, THE PHYSICIAN COULDN¿T DEFLATE THE COMPLAINT SCEPTER XC BALLOON. THE DEVICES USED WERE: BENCHMARK, HEADWAY 17, SYNCHRO STANDARD WIRE, ASAHI CHIKAI WIRE. THE COMPLAINT SCEPTER XC BALLOON WAS PREPPED UNDER IFU. THE CONTRAST AND SALINE RATIO IN BALLOON WAS 60% TO 40%, OMNIPAQUE 240 WAS USED. THE PHYSICIAN IS AN EXPERIENCE SCEPTER USER. AFTER POSITIONING THE COMPLAINT SCEPTER XC BY THE SIDE OF THE M1 ANEURYSM, HE INFLATED THE BALLOON TO TEST IT BEFORE HE COMMENCED COILING. HOWEVER, THE BALLOON FAILED TO BE DEFLATED. ATTEMPTS WERE MADE TO DEFLATE THE BALLOON WITH 1,5, AND 20ML SYRINGES. THE PHYSICIAN HAD TO REMOVE THE BALLOON WHILE IT WAS INFLATED FROM M1. THE EMBOLIZATION WAS ACHIEVED WITH ANOTHER SCEPTER XC BALLOON AND COILS. NO IMMEDIATE ADVERSE EVENT HAPPENED ON PATIENT DUE TO THIS COMPLAINT PRODUCT. THE CASE WAS COMPLETED WITH ANOTHER SCEPTER XC BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328833 ↗
• MalfunctionApr 30, 2024Material Rupture; Material Rupture

  A CORRECTION HAS BEEN MADE TO SECTION D2A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217752 ↗