SCEPTERRecalls & reported problems across all models
Microvention, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 1
- Injuries reported
- 3
- Recalls
- 0
We found 4 models of SCEPTER by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Apr 30, 2024 and Mar 17, 2026 — classified as 1 death, 3 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SCEPTER problems
Device problems
- Material Rupture10
- Deflation Problem4
- Failure to Deflate3
- Material Deformation3
- Adverse Event Without Identified Device or Use Problem1
- Air/Gas in Device1
- Contamination1
- Failure to Deliver1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Air Embolism1
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
SCEPTER models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SCEPTER BC0411XC-ID-700-ALCatheter, percutaneous1 death9 reports
- SCEPTER BC0410C-ID-700-ALCatheter, percutaneous5 reports
- SCEPTER BC0415C-ID-700-ALCatheter, intravascular occluding, temporary4 reports
- SCEPTER BC0420C-ID-700-ALCatheter, intravascular occluding, temporary2 reports
Recent SCEPTER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Material Deformation
AS REPORTED: SCEPTER BALLOON WASN'T OPENING PROPERLY (SHAPE ISSUE). HYDROSOFT COIL DIDN'T DETACH. THE PATIENT WAS REPORTED TO BE OKAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621560 ↗MalfunctionNov 25, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PHYSICIAN WAS TREATING AN ICA ANEURYSM ON THE RIGHT. A COIL EMBOLIZATION IN REMODELING TECHNIQUE WAS PLANNED. AS THE BALLOON FOR REMODELING A SCEPTER C 4-20 WAS CHOSEN. THE BALLOON WAS PREPARED WITHOUT ANY ISSUE. DURING THE THIRD INFLATION (INSIDE THE PATIENT), THE PHYSICIAN NOTICED A SUDDEN DEFLATION AND CONTRAST MEDIA RINSING FROM THE DISTAL TIP OF THE SCEPTER C. THE BALLOON WAS COMPLETELY DEFLATED AND REMOVED FROM THE PATIENT BODY. WHEN THE PHYSICIAN CHECKED THE BALLOON, THEY FOUND A LEAKAGE. THE SCEPTER C WAS EXCHANGED AND THE EXAMINATION CONTINUED WITH GOOD RESULT. THE PATIENT IS DOING WELL. NO INJURY CAUSED BY THIS ISSUE. THERE WAS NO INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23652914 ↗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 ↗MalfunctionAug 19, 2025Deflation Problem; Deflation Problem
InjuryApr 24, 2025Gas/Air Leak; Air/Gas in Device; Gas/Air Leak; Air/Gas in Device
NO ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT DESCRIPTION.
Patient problems: Air Embolism; No Clinical Signs, Symptoms or Conditions
MAUDE report 21904029 ↗MalfunctionApr 24, 2025Material Deformation; Material Deformation
AS REPORTED: PATIENT UNDERGOING ANGIOGRAPHIC ANEURYSM EMBOLIZATION. DURING THE PROCEDURE, THE CATHETER BALLOON WAS FOUND TO BE MALFORMED WHEN FULLY INFLATED. THE BALLOON WAS THEREFORE UNUSABLE. THEY USED A SECOND SCEPTER WITH SUCCESS. NO CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903802 ↗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 ↗MalfunctionMar 15, 2025Material Rupture; Material Deformation; Material Rupture; Material Deformation
IT WAS REPORT THAT THE BALLOON WAS PREPARED OUTSIDE OF THE PATIENT SUCCESSFULLY. WHEN ATTEMPTING ANEURYSM COIL REMODELING AT CAROTID/OPHTHALMIC, IT ONLY INFLATED PROXIMALLY RATHER THAN ACROSS THE WHOLE LENGTH OF THE BALLOON. THE BALLOON SHAPING WAS IRREGULAR WHEN INFLATED FOR THE THIRD TIME AT THE LEVEL OF THE ANEURYSM NECK, AND IT THEN BURST. THE PATIENT WAS TREATED WITH ANOTHER BALLOON WITH NO ISSUES, AND THE COILING WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21613842 ↗MalfunctionJan 17, 2025Material Rupture; Failure to Deflate; Material Rupture; Failure to Deflate
AS REPORTED, DURING A FLOW DIVERSION WITH PIPELINE. THE STENT WOULD NOT OPEN SO THEY ANGIO-PLASTIED WITH A SCEPTER. AFTER THEY INFLATED TO OPEN THE STENT, THE SCEPTER WOULD NOT DEFLATE. MULTIPLE SYRINGES WERE TRIED AND WOULD NOT DEFLATE. THE PHYSICIAN HAD TO PULL THE SCEPTER WHILE INFLATED AND PULLED WITHIN THE GUIDE CATHETER MAKING IT POP TO GET INSIDE. THE CASE WAS COMPLETED PER USUAL PROTOCOL. ANGIO-PLASTIED THE STENT AND REMOVED THE SCEPTER INFLATED THROUGH THE GUIDE CATHETER. NO INTERVENTION PERFORMED. THE PATIENT IS ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21186043 ↗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 ↗MalfunctionNov 5, 2024Material Rupture; Material Rupture
AS REPORTED: PATIENT TREATED FOR A LEFT SYLVIAN ANEURYSM. DURING THE PERFORMANCE OF ANGIOPLASTY, AT THE FIRST SWELLING, ON TWO OCCASIONS, A RUPTURE OF THE BALLOON OCCURS. THE LINING OF THE BALLOONS APPEARS TO BE STREAKED, WHICH LED TO A CRACK WHEN THEY WERE INFLATED. WHEN THE SECOND BALLOON RUPTURED, IT WAS A SUDDEN LOSS OF PRESSURE. NO CONSEQUENCES FOR THE PATIENT. THIS REPORT IS FOR THE SECOND BALLOON RUPTURE OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20606006 ↗MalfunctionNov 4, 2024Material Rupture; Material Rupture
AS REPORTED: PATIENT TREATED FOR A LEFT SYLVIAN ANEURYSM. DURING THE PERFORMANCE OF ANGIOPLASTY, AT THE FIRST SWELLING, ON TWO OCCASIONS, A RUPTURE OF THE BALLOON OCCURS. THE LINING OF THE BALLOONS APPEARS TO BE STREAKED, WHICH LED TO A CRACK WHEN THEY WERE INFLATED. WHEN THE FIRST BALLOON RUPTURED, IT WAS A SUDDEN LOSS OF PRESSURE. NO CONSEQUENCES FOR THE PATIENT. THIS REPORT IS FOR THE FIRST BALLOON RUPTURE OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20604687 ↗MalfunctionOct 29, 2024Contamination; Contamination
Other Microvention, Inc. products
- Azur CX Detachable22 models · 509 reports · 1 recall
- Stent63 models · 237 reports · 2 recalls
- Azur Detachable Helical HydroCoil42 models · 190 reports
- V-Trak75 models · 147 reports
- WEB14 models · 134 reports
- AZUR14 models · 104 reports
- HydroSoft 3D26 models · 101 reports
- MicroPlex Helical Soft9 models · 8 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page