HyperForm 104-4715Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000294298), received between Aug 10, 2022 and Nov 17, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Deflation Problem; Deflation Problem

  ADDITIONAL INFORMATION WAS RECEIVED. VESSEL TORTUOSITY WAS ASSESSED AS MODERATE. THE DEVICE WAS PREPARED ACCORDING TO THE IFU, INCLUDING INSPECTION AND HYDRATION. THE CAUSE OF THE EVENT IS UNKNOWN. THE PHYSICIAN TESTED THE BALLOON PRIOR TO USE, AND IT PERFORMED AS INTENDED DURING TESTING. IODINATED ALCOHOL WAS USED AS THE CONTRAST AGENT. THE GUIDEWIRE TIP WAS ADVANCED MORE THAN 3 CM OUT OF THE CATHETER TIP DURING INFLATION, AND A 1 ML SYRINGE WAS USED FOR BALLOON INFLATION AND DEFLATION. IT IS UNKNOWN WHETHER BLOOD REFLUXED INTO THE BALLOON LUMEN. NO FRICTION OR DIFFICULTY WAS ENCOUNTERED DURING INFLATION. AFTER MULTIPLE INFLATIONS, THE CATHETER AND GUIDEWIRE WERE EXAMINED FOR CLOT AT THE TIP OR INFLATION HOLES, AND NO THROMBOSIS WAS FOUND. NO EXTENSIVE GUIDEWIRE MANIPULATION OCCURRED DURING THE PROCEDURE. NO KINK OR DAMAGE WAS OBSERVED ON EITHER THE CATHETER OR THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569561 ↗
• MalfunctionJul 9, 2025Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS PLANNED TO UNDERGO EMBOLIZATION OF A RIGHT LENTICULOSTRIATE ARTERY ANEURYSM USING THIS CONSUMABLE. OCCLUSION OF THE MIDDLE CEREBRAL ARTERY WAS INTENDED TO FACILITATE THE EMBOLIZATION. DURING BALLOON INFLATION, THE BALLOON BURST. HEALTHCARE PROVIDER (HCP) REPLACED IT WITH ANOTHER BALLOON FOR USE TO COMPLETE THE PROCEDURE. THIS EVENT SERIOUSLY AFFECTED THE PROGRESS OF SURGERY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR VESSEL OCCLUSION TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459891 ↗
• MalfunctionMay 29, 2025Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE FIRST BALLOON BURST, SO WE REPLACED IT WITH THE SECOND ONE. THE SECOND ONE BURST AGAIN, SO WE REPLACED IT WITH THE THIRD ONE. THEN THE OPERATION WAS SUCCESSFULLY COMPLETED. THE CAUSE OF THE BURSTS WAS NOT DETERMINED. BECAUSE THE BALLOON HAD BEEN DISCARDED IT WAS UNCLEAR WHERE WAS THE BALLOONS' LEAK WAS. NO CARTRIDGE SYRINGES WERE USED, AND IT WAS UNCLEAR WHAT SYRINGES WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107003 ↗
• MalfunctionMar 10, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE BALLOON BEING BROKEN WAS NOT DETERMINED. THE PHYSICIAN TESTED THE BALLOON PRIOR TO USE. THE BALLOON DID NOT PERFORM AS INTENDED DURING TESTING. THE PHYSICIAN SHAPED THE GUIDEWIRE TIP. THE INJECTION RATE WAS STEADY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562386 ↗
• MalfunctionJun 26, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE SURGEON WAS TESTING THE BALLOON DURING THE OPERATION, THEY FOUND THAT THE BALLOON WAS LEAKING AND COULD NOT WORK PROPERLY, SO THEY REPLACED IT WITH ANOTHER PRODUCT FOR THE OPERATION. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613477 ↗
• MalfunctionOct 30, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ON (B)(6) 2023 MPXR 1111735 (REP, HCP, FOR, DIS): MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE PACKAGE AND PERFORMING HYDRATION, IT WAS DISCOVERED THAT THE BALLOON WAS LEAKING AND COULD NOT BE INFLATED. REPLACED THE PRODUCT TO COMPLETE THE SURGERY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029150 ↗
• InjuryJan 19, 2023Difficult to Advance; Difficult to Advance

  MEDTRONIC RECEIVED A REPORT THAT DURING BALLOON-ASSISTED EMBOLIZATION OF ANEURYSM, THE OCCLUSION BALLOON CATHETER SYSTEM COULD NOT PASS THROUGH THE PARENT ARTERY. THE ADAPTIVE GUIDE WIRE PASSED THROUGH THE BEND OF CAVERNOUS SINUS BLOOD VESSEL, AND THE GUIDE WIRE FORMED A LOOP IN THE VASCULAR LUMEN. MANY ATTEMPTS FAILED, WHICH LED TO THE FAILURE OF BALLOON-ASSISTED EMBOLIZATION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16204135 ↗
• MalfunctionAug 10, 2022Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED INFORMATION REGARDING A RUPTURED HYPERFORM BALLOON. IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR A LEFT INTERNAL CAROTID ARTERY (ICA) TUMOR AND THE HYPERFORM BALLOON WAS BEING USED IN A BALLOON TEST OCCLUSION. THE HYPERFORM BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE HYPERFORM WAS THEN INSERTED THROUGH THE SHEATH AND GUIDE CATHETER AND INFLATED USING A MEDTRONIC CADENCE SYRINGE TO 0.20CC (5.7MM BALLOON SIZE). THE BALLOON WAS NOTED TO BE LOSING PRESSURE SO THE DOCTOR REMOVED IT AND NOTED CONTRAST EXITING THE DISTAL TIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204167 ↗