Scepter CRecalls & reported problems across all models
Microvention, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 4 models of Scepter C by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2017 and Sep 13, 2024 — classified as 3 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (17 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 C problems
Device problems
- Material Rupture17
- Deflation Problem5
- Adverse Event Without Identified Device or Use Problem2
- Improper or Incorrect Procedure or Method2
- Off-Label Use2
- Failure to Deflate1
- Failure to Fold1
Patient problems
- No Consequences Or Impact To Patient18
- No Clinical Signs, Symptoms or Conditions4
- Vascular System (Circulation), Impaired2
- Hemorrhage, Subarachnoid1
- Perforation of Vessels1
- Rupture1
- Thrombus1
Scepter C models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Scepter C BC0410C-IDCATHETER, PERCUTANEOUS16 reports
- Scepter C BC0415C-IDCATHETER, PERCUTANEOUS8 reports
- Scepter C BC0415CCATHETER, PERCUTANEOUS1 report
- Scepter C BC0420C-IDCATHETER, PERCUTANEOUS1 report
Recent Scepter C adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2024Material Rupture; Material Rupture
AS REPORTED: INTERNAL CAROTID CAVERNOUS SINUS LEAK (LEFT SIDE). DURING THE PROCEDURE, FOUND THAT THE BALLOON WAS RUPTURED AFTER FILLING TO 0.4CC, AND THE WHOLE DEVICE WAS REMOVED. EXAMINATION OF THE PATIENT'S BLOOD VESSELS SHOWED NO ABNORMALITY. AFTER READJUSTING THE POSITION, REPLACED WITH A NEW 4*20 BALLOON, WHICH WAS FILLED TO 0.4CC WITHOUT ABNORMALITIES AND THE EFFECT WAS SATISFACTORY. THE MICROCATHETER WAS IN PLACE, 8 COILS SUCH AS 20* 50,18 * 44,16 *39 WERE FILLED SUCCESSIVELY, AND 8 GLUE WERE INJECTED THROUGH OTHER MICROCATHETER. THE ANGIOGRAPHY EFFECT WAS SATISFACTORY AND THE PROCEDURE WAS COMPLETED. THE SIDE WALL LIQUID OF THE BALLOON IS SQUEEZES LIQUID OUT, IN A JET SHAPE, AND THE SIDE WALL OF THE BALLOON HAS HOLES. PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20218505 ↗MalfunctionAug 26, 2024Material Rupture; Material Rupture
AS REPORTED: INTRAOPERATIVE PRESSURE TO 0.30CC, THE BALLOON BURST IN THE RATED RANGE. THE PROCEDURE WAS COMPLETED AFTER THE SAME TYPE OF BALLOON WAS REPLACED. IT WAS A SUDDEN LOSS OF PRESSURE WHEN THE BALLOON BURST. PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20072029 ↗MalfunctionFeb 26, 2021Deflation Problem; Deflation Problem
IT WAS REPORTED THAT THE BALLOON DID NOT CORRECTLY DEFLATE DURING THE PROCEDURE. THE BALLOON WAS REMOVED WHILE MOSTLY INFLATED. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11389405 ↗MalfunctionDec 23, 2020Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED DURING THE PROCEDURE. THE BALLOON WAS REMOVED THROUGH THE INTERMEDIATE CATHETER WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11069631 ↗MalfunctionAug 20, 2020Deflation Problem; Deflation Problem
IT WAS REPORTED THAT AFTER INFLATION IN THE PATIENT, THE BALLOON DEFLATION WAS TOO SLOW. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10435237 ↗InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT EMBOLIZATION TREATMENT WAS ATTEMPTED FOR A MENINGIOMA. DURING THE INJECTION OF A LIQUID EMBOLIC AGENT (SQUID 18) THROUGH THE SCEPTER BALLOON CATHETER, NOTHING APPEARED TO EXIT FROM THE DISTAL BALLOON LUMEN; HOWEVER, A LEAKAGE OF THE SQUID WAS OBSERVED AT THE LEVEL OF A BRANCH OF THE EXTERNAL CAROTID ARTERY. THE INJECTION WAS STOPPED AND ARTERIOGRAPHY OF THE RIGHT EXTERNAL CAROTID AND RIGHT COMMON CAROTID ARTERIES DEMONSTRATED "SLOWED DOWN BUT PERSISTENT" FLOW WITHIN THE RIGHT INTERNAL MAXILLARY ARTERY. THERE WAS NO REFLUX WITHIN THE BRANCHES OF THE RIGHT INTERNAL CAROTID ARTERY. NO ADDITIONAL INTERVENTION WAS PERFORMED. POST-PROCEDURE, THE PATIENT EXPERIENCED HEMIFACIAL PAIN UPON AWAKENING THAT WAS TREATED WITH ANTALGIC. THE CLINICAL CONSEQUENCES OF THE EVENT INCLUDED "AN EXTENSION OF THE INTERVENTION, INCOMPLETE EMBOLIZATION OF THE RIGHT MIDDLE MENINGEAL ARTERY DUE TO OFF-SITE EMBOLIZATION WITHIN THE INTERNAL MAXILLARY ARTERY, AND A RISK OF EMBOLIZATION OF THE ARTERIAL BRANCHES OF THE EXTERNAL CAROTID ARTERY." NO ADDITIONAL ACTIONS WERE TAKEN AT THE FACILITY FOR CARE OF THE PATIENT. THERE WAS NO REPORTED NEUROLOGICAL DEFICIT OR SEQUELA AS A RESULT OF THE EVENT
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 10068342 ↗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 9975002 ↗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 9974919 ↗MalfunctionNov 21, 2019Failure to Fold; Failure to Fold
IT WAS REPORTED THAT DURING BALLOON-ASSISTED COILING OF AN INTERNAL CAROTID ARTERY ANEURYSM, THE BALLOON WAS NOT DEFLATING RAPIDLY AFTER INFLATING AND DEFLATING 2-3 TIMES. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9359987 ↗InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A SUBARACHNOID HEMORRHAGE, HUNT AND HESS GRADE 2. CT IMAGING DEMONSTRATED TWO ANEURYSMS IN THE ANTERIOR COMMUNICATING ARTERY, FISHER SCALE GRADE 2. ON (B)(6) 2019, BALLOON ASSISTED COIL EMBOLIZATION WAS ATTEMPTED AS TREATMENT. THE SCEPTER BALLOON WAS INFLATED IN THE ACOM ARTERY WITH ITS DISTAL END IN THE LEFT A2 SEGMENT AND THE PROXIMAL END IN THE RIGHT A1 SEGMENT. AFTER PLACEMENT OF THE SECOND COIL IN THE LARGER ANEURYSM, CONTROL ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION NEAR THE SMALLER LEFT-SIDED ANEURYSM, WHICH WAS LIKELY A NECK RUPTURE DURING INFLATION OF THE BALLOON. A FOLLOW-UP ANGIOGRAM REVEALED THAT THE CONTRAST EXTRAVASATION HAD SUBSIDED, AND THERE APPEARED TO BE AN AREA OF ACUTE THROMBUS FORMATION NEAR THE NECK OF THE SMALLER ANEURYSM, WHICH LIKELY OCCLUDED THE RUPTURE SITE. A DILATION OF THE PROXIMAL A2 SEGMENT OF THE LEFT ACOMM ARTERY WAS ALSO NOTED, WHICH WAS LIKELY INDICATIVE OF A PSEUDOANEURYSM. COIL EMBOLIZATION OF THE SMALLER ANEURYSM RESUMED, AND FOLLOW-UP ANGIOGRAMS DEMONSTRATED THE COIL MASS WAS WELL SEATED WITHIN THE LARGER ANEURYSM, THE PARENT VESSEL WAS WIDELY PATENT, AND THERE WAS NO FURTHER EVIDENCE
Patient problems: Hemorrhage, Subarachnoid; Rupture; Thrombus
MAUDE report 8963145 ↗MalfunctionJul 31, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON RUPTURED IN THE PATIENT DURING THE PROCEDURE. THERE WAS NO REPORTED INTERVENTION, PATIENT INJURY, OR HEALTH DAMAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8848532 ↗MalfunctionJul 24, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON SUDDENLY DEFLATED IN THE PATIENT DURING THE PROCEDURE. THERE WAS NO REPORTED INTERVENTION, PATIENT INJURY, OR HEALTH DAMAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8823770 ↗MalfunctionMay 16, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE SCEPTER C BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8616697 ↗InjuryMay 7, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING THE TREATMENT OF A MIDDLE MENINGEAL ARTERY, ONYX WAS DELIVERED THROUGH THE SCEPTER C BALLOON CATHETER, AND THE BALLOON CATHETER RUPTURED APPROXIMATELY 10CM FROM THE BALLOON. ONYX LEAKED FROM THE CATHETER AND CAUSED COMPLETE OCCLUSION OF THE SPHENOPALATINE ARTERY. THERE WAS NO REPORTED ISSUE WITH THE REMOVAL OF THE BALLOON CATHETER. THE PATIENT'S CONDITION WAS REPORTED TO BE AT BASELINE.
Patient problems: Vascular System (Circulation), Impaired
MAUDE report 8589124 ↗MalfunctionApr 23, 2019Deflation Problem; Deflation Problem
IT WAS REPORTED THAT A STENT WAS IMPLANTED IN THE INTERNAL CAROTID ARTERY AND THE SCEPTER BALLOON WAS INFLATED TO POST-DILATE THE STENT; HOWEVER, THE BALLOON COULD NOT BE DEFLATED. ATTEMPTS TO DEFLATE THE BALLOON WITH A 3ML AND A 20ML SYRINGE WERE UNSUCCESSFUL AND THE INFLATED BALLOON WAS REMOVED THROUGH THE STENT. THERE WAS NO MOVEMENT OF THE STENT FROM ITS IMPLANTED POSITION DURING THE BALLOON RETRACTION. THERE WAS NO REPORTED PATIENT INJURY OR PROCEDURAL CLINICAL CONSEQUENCE, AND NO INTRA-PROCEDURAL MEDICATIONS WERE GIVEN TO THE PATIENT OUTSIDE OF NORMAL PROCEDURE PROTOCOL AT THE TIME OF THE EVENT OR POST-PROCEDURE. THE PATIENT WAS REPORTED TO BE DOING WELL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8541751 ↗
Other Microvention, Inc. products
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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