SCEPTER BC0420C-ID-700-ALRecalls & reported problems
Microvention, Inc. · Scepter C · Class 2
All models of SCEPTER (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429117569), received between Mar 15, 2025 and Nov 25, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
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- TRANSFORM M003SSC07070Stryker Corporation · Catheter, intravascular occluding, temporary17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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