Balloon CatheterRecalls & reported problems across all models

We found 5 models of Balloon Catheter by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2020 and Apr 10, 2026 — classified as 2 deaths, 19 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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

Most reported Balloon Catheter problems

Balloon Catheter models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Balloon Catheter BC0210M-US

  Catheter, percutaneous
  16 reports
• Balloon Catheter BC0411XC-ID-700

  Catheter, percutaneous
  2 deaths13 reports
• Balloon Catheter BC0410C-ID-700

  Catheter, intravascular occluding, temporary
  12 reports
• Balloon Catheter BC0420C-ID-700

  Catheter, percutaneous
  7 reports
• Balloon Catheter BC0415C-ID-700

  Catheter, percutaneous
  6 reports

Recent Balloon Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Material Fragmentation

  AS REPORTED: WITNESSED A DEVICE MALFUNCTION OF THE SCEPTER MINI CATHETER BREAKING OFF THE TIP DURING AN AVM TREATMENT. THE TIP WAS LEFT IN THE SUBJECT, PARKED IN THE IMA AT THE POINT OF EMBOLIZATION. THE SUBJECT HAD NO ADDITIONAL COMPLICATION KNOWN AND WAS STABLE FOLLOWING THE PROCEDURE. THE EVENT WAS NOT A CLINICAL CASE. THERE WAS MANIPULATION OF THE TIP TO GET IT PARKED IN THE IMA. THEY ATTEMPTED TO SNARE IT USING A 4MM AND 8MM SNARE WHEN THE TIP WAS IN THE CCA, BUT IT WAS NOT BIG ENOUGH AND EVENTUALLY MIGRATED UP THE ECA. FROM THERE DR. DECIDED IT WAS NO RISK TO PARK THE TIP IN THE IMA AT THE POINT OF EMBOLIZATION OF THE MALFORMATION GIVEN THE TIP WOULD NOT BE ABLE TO MIGRATE BEYOND THAT POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24841886 ↗
• InjuryDec 16, 2025Entrapment of Device; Material Fragmentation; Entrapment of Device; Material Fragmentation

  IT WAS REPORTED THAT DURING A CERVICAL ANGIOGRAM AND RIGHT MIDDLE MENINGEAL ARTERY EMBOLIZATION USING ONYX, THE SCEPTER MINI BALLOON CATHETER BROKE AND REMAINED INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED RETRIEVAL USING A RETRIEVAL BALLOON (COMPLETE GOOSENECK MICRO-SNARE KIT); HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. THE BALLOON CATHETER WAS NOT FULLY RETRIEVED. THE PROCEDURE WAS COMPLETED IN THE USUAL MANNER. THERE WAS NO REPORTED PATIENT HARM. THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT AND WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817991 ↗
• InjuryDec 5, 2025Entrapment of Device; Material Fragmentation; Entrapment of Device; Material Fragmentation

  PLEASE SEE SECTION H11 FOR DEVICE INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735554 ↗
• MalfunctionOct 17, 2025Material Rupture; Material Rupture

  AS REPORTED, DURING A CEREBRAL ANGIOGRAM, MMA EMBOLIZATION, THE SCEPTER MINI BALLOON WAS USED DURING TREATMENT OF MMA EMBO AND BURST WHEN THE FELLOW WAS TAKING THE BALLOON OUT. NO INJURY OCCURRED BUT THE BALLOON WAS NOT USABLE. NO INJURY OCCURRED BUT THE BALLOON WAS NOT USABLE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331028 ↗
• InjurySep 9, 2025Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON CATHETER WAS USED IN AN EMBOLIZATION PROCEDURE WITH LIQUID EMBOLIC TO TREAT A PATIENT WITH A DURAL AV FISTULA. REPORTEDLY, DURING PREPARATION OF THE BALLOON, THERE WAS DIFFICULTY INFLATING AND DEFLATING THE BALLOON WITH A 1CC SYRINGE. THE BALLOON FILLED UP WITH CONTRAST WITH NO AIR SEEN INSIDE THE BALLOON; HOWEVER, THE BALLOON DID NOT DEFLATE AND REINFLATE AT ALL. WHILE KEEPING PRESSURE WITH THE 1CC SYRINGE , THE PHYSICIAN OBSERVED A MOVEMENT FROM THE BALLOON WHILE INFLATING THINKING THAT WAS THE SELF-SEALING OCCURRING. NO AIR WAS OBSERVED IN THE BALLOON. THE PHYSICIAN THEN SUBMERGED THE BALLOON INTO HEPARINIZED SALINE AND DEFLATED BALLOON WITH NO ISSUES. THE 1CC SYRINGE WAS REMOVED AND REPLACED WITH A .25CC SYRINGE AND PLACED ON INFLATION PORT AND THE BALLOON WAS INSERTED INTO THE PATIENT OVER A GUIDEWIRE. THE LIQUID EMBOLIC WAS PREPARED AND INSERTED AT THE GUIDEWIRE PORT. WHEN THE BALLOON WAS INFLATED WITH 100% 270MG/ML VISIPAQUE CONTRAST WITH THE .25 SYRINGE, THE BALLOON INFLATED AT THE PROXIMAL END OF THE BALLOON WITH IRREGULAR SHAPE AND THE DISTAL END OF THE BALLOON DID NOT INFLATE AS BIG AS THE PROXIMAL END. HOWEVER, THE PHYSICIAN THOUGHT THIS

  Patient problems: Vasoconstriction

  MAUDE report 23000476 ↗
• InjuryApr 25, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A SCEPTER C BALLOON 4 X 20 COULD NOT BE DEFLATED DURING A BALLOON ASSISTED COILING OF RUPTURED LARGE (L) SUPERIOR HYPOPHYSIAL ARTERY ANEURYSM PROCEDURE. DIFFICULT ACCESS. HAD TO LOOP THE CATHETER IN THE ANEURYSM TO GET THE OUTFLOW. INFLATED THE BALLOON IN MCA TO GET RID OF THE LOOP. BALLOON STAYED INFLATED DESPITE USING 60 CC SYRINGE. COULD HAVE KINKED THE CATHETER WITH THAT MANEUVER. PERHAPS THE GUIDEWIRE SHOULD HAVE BEEN LEFT IT IN THE CATHETER. BALLOON WAS PREP THE USUAL WAY AND DEFLATED NORMALLY PRIOR TO INSERTION. ADDITIONALLY REPORTED: LOOPED BALLOON INSIDE ANEURYSM TO FIND OUTFLOW AND INFLATED IN MCA AND STRAIGHTENED OUT LOOP. BALLOON INFLATED BUT WOULD NOT DEFLATE. BALLOON INFLATED AND DEFLATED WELL ON TESTING IN PETROUS ICA. BUT AFTER GETTING DISTAL TO ANEURYSM (TORTUOUS ANATOMY) BALLOON INFLATED BUT WOULD NOT DEFLATE. THE CASE WAS COMPLETED WITH COILS. THE PATIENT WAS REPORTED TO BE DOING GOOD. NO HARM DONE ON PATIENT. THE PATIENT IS CLINICALLY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914621 ↗
• MalfunctionAug 23, 2024Material Rupture; Material Rupture

  AS REPORTED: THE BALLOON WAS DEFLATED WITH SALINE AND RUPTURED WHEN THE PHYSICIAN INFLATED IT WITH CONTRAST-MIXED SALINE. ACCORDING TO THE PHYSICIAN, WHEN THE BALLOON RUPTURED, THERE WAS A SUDDEN LOSS OF PRESSURE. THE PHYSICIAN TEMPORARILY STOPPED THE PROCEDURE AND REMOVED THE DEVICE TO ENSURE THE SAFETY OF THE PATIENT. THE PATIENT IS UNDER OBSERVATION, WITH NO FURTHER CLINICAL CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20045631 ↗
• InjuryJul 24, 2024Entrapment of Device; Failure to Deliver; Entrapment of Device; Failure to Deliver

  IT WAS REPORTED THAT THE SCEPTER MINI WAS SELECTED FOR A SECOND AVM TREATMENT. THE PHYSICIANS FOLLOWED EVERY STEP OF THE PREPARATION SHEET OF SCEPTER MINI. PREPARATION WAS ACCORDING PROTOCOL, NO ISSUES. DMSO AND SQUID WENT WELL, NO BLOCK OF THE CATHETER. THEY MARKED ON THE SCREEN THE NIDUS OF THE AVM AND THE BALLOON. HOWEVER, AFTER 30 MINUTES AND 2 SYRINGES OF SQUID, THEY FOUND OUT THAT SQUID WENT PROXIMAL AROUND THE SCEPTER MINI BALLOON. BALLOON WAS STUCK IN THE AVM WITH SQUID. PHYSICIAN DECIDED TO CUT OFF THE SCEPTER MINI IN THE FEMORAL. THEY TRIED WITH SECOND SCEPTER MINI, EVERYTHING WENT WELL, NO ISSUES. FIRST CONE BEAM CT WAS PERFORMED, PATIENT WENT FOR SURGERY. AND THEY TOOK OF THE AVM AND SCEPTER MINI. IN CONCLUSION: SCEPTER MINI PERFORMED GOOD, HOWEVER WRONG SEGMENT WAS SELECTED BY PHYSICIAN. DUE TO ANOTHER FLOW IN AVM, THE PATIENT NEEDED SURGERY INSTEAD OF EMBOLIZATION. THE PATIENT DIDN¿T WAKE UP THAT GOOD AFTER CERVICAL SURGERY TO REMOVE THE AVM.

  Patient problems: Foreign Body In Patient

  MAUDE report 19819892 ↗
• MalfunctionJul 3, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A SCEPTER BALLOON CATHETER DID NOT DEFLATE DURING A COIL EMBOLIZATION PROCEDURE. THE DEVICE WAS REMOVED IN AN INFLATED STATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THE PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662926 ↗
• InjuryJun 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING CONTRAST INJECTION THROUGH THE BALLOON CATHETER, THE BALLOON INFLATED AND RUPTURED ALONG WITH THE VESSEL. THE SCEPTER MINI WAS USED TO DELIVER ONYX INTO THE VESSEL THEN REMOVED. STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME.

  Patient problems: Cognitive Changes; Intracranial Hemorrhage; Perforation of Vessels; Rupture; Ruptured Aneurysm

  MAUDE report 19581819 ↗
• MalfunctionMay 9, 2024Material Rupture; Material Rupture

  AS REPORTED: DURING THE BALLOON-ASSISTED-COILING OF A MEDIA ANEURYSM, THE BALLOON BURST WITHIN THE VESSEL. THE BALLOON WASN'T INFLATED COMPLETELY ¿ AROUND 50-70%. WHEN THE BALLOON HAD BURST, THERE WAS A QUICK LOSS OF VOLUME IN A SHORT TIME. THE EVENT HAD NO INFLUENCE ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280646 ↗
• MalfunctionApr 18, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE DOCTOR OBSERVED DEBRIS FLOATING IN THE SCEPTER XC BALLOON DURING DEVICE PREPARATION. THIS WAS REALIZED DURING INJECTION OF CONTRAST SOLUTION THROUGH BALLOON INFLATION PORT. THE DEVICE WAS NOT USED AND WAS DISCARDED, A NEW SCEPTER XC WAS SELECTED. THE DEVICE WAS NOT USED IN PATIENT; NO NEGATIVE OUTCOME CAUSED BY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134009 ↗
• MalfunctionApr 15, 2024Gas/Air Leak; Gas/Air Leak

  PLEASE SEE SECTION H11 FOR DEVICE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111616 ↗
• InjuryMar 20, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN ONYX EMBOLIZATION TREATMENT IN THE LEFT OPHTHALMIC ARTERY TO TREAT A TUMOR. WHEN THE EMBOLIZATION PROCEDURE WAS OVER, THE PHYSICIAN TRIED TO REMOVE THE BALLOON. ONYX WAS ADHERED TO BALLOON AND THE BALLOON CATHETER DID NOT WANT TO COME OUT. THE BALLOON CATHETER BROKE, AND SOME OF THE BALLOON CATHETER REMAINED IN THE GUIDE CATHETER AND BLOOD VESSEL. THE PHYSICIAN USED A TREVO DEVICE TO REMOVE A LARGE SEGMENT OF THE BALLOON CATHETER THAT REMAINED. THERE WAS STILL A FRAGMENT OF THE BALLOON CATHETER THAT REMAINED IN THE BODY. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18946753 ↗
• MalfunctionJan 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499918 ↗

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