Balloon Catheter BC0210M-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00842429106563), received between Jan 9, 2021 and Apr 10, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (5 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryJan 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE BALLOON WAS PREPPED PER THE IFU. ATTEMPTED USE IN RIGHT AICA ARTERY AND THE BALLOON WAS DELIVERED AND INFLATED TO NOMINAL PRESSURE. DMSO DELIVERED, ONYX ATTEMPTED DELIVERY FOLLOWED. ONYX APPEARED TO BE REFLUXING PROXIMAL TO THE INFLATED BALLOON. INJECTION STOPPED AND PHYSICIAN ATTEMPTED TO DEFLATE BALLOON TWICE. PHYSICIAN THEN TRIED TO REMOVE BALLOON CATHETER. THE BALLOON THEN DETACHED FROM THE CATHETER BEING STUCK IN THE VESSEL WHILE REMAINING INFLATED. DURING THIS ACTION THE VESSEL RUPTURED. A COIL WAS PLACED IN THE R AICA ARTERY PROXIMAL TO THE BALLOON THAT CAME OFF OF THE SCEPTER MINI. ACTIVE BLEEDING WAS RECORDED FOR APPROXIMATELY 6 MINUTES. PATIENT WAS STABILIZED AND SENT TO ICU AND WAS REPORTED TO BE DISCHARGED SOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472130 ↗
• InjuryJun 21, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING TREATMENT WITH ONYX, THE LIQUID EMBOLIC WAS REPORTED TO REFLUX AROUND THE SCEPTER MINI DEVICE. UPON RETRACTION OF THE DEVICE, THE CATHETER SEEMED TO HAVE STRETCHED AND DETACHED IN THE ECA. 90 PERCENT OF THE CATHETER WAS REMOVED MANUALLY, THE MOST DISTAL 10 PERCENT SEGMENT REMAINED IN THE ECA. ADDITIONAL ONYX WAS DELIVERED. THE PATIENT WOKE UP WITH NO DEFICIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17176435 ↗
• InjuryMay 11, 2023Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT DURING AN ARTERIAL VENOUS FISTULA (AVF) PROCEDURE, THE PHYSICIAN WAS PREPPING THE SCEPTER MINI BALLOON DEVICE AND IT APPEARED TO NOT FULLY OPEN AT PREPPING. HOWEVER, THE PHYSICIAN DECIDED TO CONTINUE TREATMENT WITH THE BALLOON AND INJECT LIQUID EMBOLIZATION THROUGH IT. WHEN THE PHYSICIAN WAS COMPLETED WITH THE INJECTION, IT WAS NOTICED THAT THE DEVICE FELT STUCK. THE PHYSICIAN WAS ABLE TO PULL THE DEVICE OUT OF THE PATIENT AFTER RESISTANCE AND IT WAS NOTED THAT THE DEVICE LOOKED STRETCHED AND THAT THE DISTAL TIP OF THE BALLOON CATHETER WAS MISSING AND LEFT IN THE PATIENT. THE PHYSICIAN OPENED A SECOND SCEPTER MINI DEVICE TO CONTINUE INJECTIONS IN A DIFFERENT LOCATION IN THE BODY. THE PHYSICIAN HAS NO CONCERNS AND PATIENT IS WELL. EVERYTHING IS ENTRAPPED AND STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912872 ↗
• InjuryApr 25, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  PLEASE SEE SECTION H10 FOR THE IMAGE REVIEW OF FIVE (5) RECEIVED CUSTOMER SUPPLIED IMAGES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812110 ↗
• InjuryMar 30, 2023Material Rupture; Material Rupture

  AS REPORTED, DURING TREATMENT USING A SCEPTER MINI AND ONYX, THE DOCTOR EMBOLIZED AN MMA. THE BALLOON RUPTURED TOWARD THE END OF THE PROCEDURE, AND THE END PIECE GOT STUCK IN THE ONYX. THE REST OF THE BALLOON CATHETER WAS REMOVED USING SNARES. IMAGE AND OPERATIVE REPORT WERE REQUESTED AND WERE REPORTED AS NOT AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS STABLE WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16652903 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR A SMALL ARTERIOVENOUS MALFORMATION (AVM) IN THE RIGHT HEMISPHERE OFF THE MIDDLE CEREBRAL ARTERY (MCA). THE PHYSICIAN SELECTED THE APPROPRIATE PEDICLE FEEDING ARTERY INTO THE AVM FROM THE RIGHT MCA BRANCH, INFLATED THE SCEPTER MINI, AND PROCEEDED TO ONYX THE PEDICLE AND AVM. THE ONYX WAS FILLING AROUND THE BALLOON IMMEDIATELY AND WAS INDICATING EXTRAVASATION OUTSIDE OF THE BLOOD VESSEL. AFTER AN ANGIOMA RUN, THE PEDICLE VESSEL WAS SHOWN TO BE RUPTURED. THE SCEPTER BALLOON WAS REMOVED AND AFTER A FEW MORE ANGIOMA RUNS, THE BLEEDING VESSEL OCCLUDED ALONG WITH THE AVM. THE INDICATION FROM THE PHYSICIAN WAS THE PATIENT APPEARED TO BE OK WHEN WAKING UP.

  Patient problems: Ruptured Aneurysm

  MAUDE report 15729080 ↗
• InjuryMar 24, 2022Break; Break

  IT WAS REPORTED THAT DURING AN AVF TREATMENT, A SCEPTER MINI BALLOON CATHETER WAS USED TO DELIVER LIQUID EMBOLIC. REFLUX OF THE LIQUID EMBOLIC WAS OBSERVED. THE BALLOON CATHETER WAS DIFFICULT TO REMOVE AND BROKE INTO TWO SEGMENTS. THERE WAS NO REPORTED HARM TO THE PATIENT AND NO REPORTED INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895620 ↗
• InjuryFeb 8, 2022Break; Break

  IT WAS REPORTED THAT DURING AN AVM EMBOLIZATION CASE, TORTUOUS ANATOMY WAS ENCOUNTERED AND A SCEPTER MINI BALLOON CATHETER WOULD NOT ADVANCE FURTHER, STOPPED AT A HORSESHOE-SHAPED TURN. IT WAS DECIDED TO DEPLOY LIQUID EMBOLIC AT THAT POINT INSTEAD OF A MORE DISTAL POSITION. AFTER EMBOLIZATION, THE SCEPTER MINI WAS WITHDRAWN AND IT APPEARED THAT THE BRAIDING IN THE SHAFT HAD PULLED APART. THE DISTAL PART OF THE SCEPTER WAS STUCK OUTSIDE THE DISTAL END OF THE INTERMEDIATE CATHETER; THE OTHER PORTION OF IT WAS WITHIN THE INTERMEDIATE CATHETER. THE DISTAL PORTION OF THE SCEPTER WAS SNARED AFTER MULTIPLE ATTEMPTS AND WAS WITHDRAWN IN ITS ENTIRETY ALONG WITH THE INTERMEDIATE CATHETER. THE PROCEDURE'S COMPLETION WAS DELAYED BETWEEN TWO AND THREE HOURS. THE PATIENT WAS REPORTED TO BE "OK" AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13488244 ↗
• InjuryJan 9, 2021Break; Failure to Deflate; Break; Failure to Deflate

  IT WAS REPORTED THAT DURING EMBOLIZATION OF AN AVM WITH A LIQUID EMBOLIC, THE SCEPTER MINI WOULD NOT DEFLATE AND THEN COULD NOT BE REMOVED FROM THE SUPERIOR CEREBELLAR ARTERY (SCA). DURING AN ATTEMPT TO REMOVE THE SCEPTER WITH A SNARE DEVICE, THE BALLOON DETACHED FROM THE CATHETER IN THE SCA. THE PROXIMAL SEGMENT OF THE SCA BECAME OCCLUDED AND CEREBRAL INFARCTION DEVELOPED, LEADING TO BRAINSTEM COMPRESSION AND HYDROCEPHALUS. VENTRICULAR DRAINAGE, AVM REMOVAL, AND EXTERNAL DECOMPRESSION WERE PERFORMED.

  Patient problems: Hydrocephalus; Ischemia Stroke; Obstruction/Occlusion

  MAUDE report 11143923 ↗