SCEPTER BC0415C-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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429117552), received between Nov 4, 2024 and Aug 19, 2025 — classified as 4 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
- Deflation Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2025Deflation Problem; Deflation Problem
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 ↗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 ↗
Other Catheter, intravascular occluding, temporary devices
- Pruitt F3 Carotid Shunt 2012-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary1 death158 reports
- GORE Molding Occlusion Balloon Catheter MOB37W. L. Gore & Associates, Inc. · Catheter, Intravascular Occluding, Temporary6 deaths152 reports
- Bridge Occlusion Balloon 590-001Spectranetics Corporation · Catheter, Intravascular Occluding, Temporary4 deaths57 reports
- Pruitt F3 Carotid Shunt e2012-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary53 reports
- Pruitt F3 Carotid Shunt 2013-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary46 reports
- Equalizer™ M001171100Boston Scientific Corporation · Catheter, intravascular occluding, temporary18 reports
- Pruitt F3 Carotid Shunt e2013-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary17 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page