HyperForm 104-4770 (UDI 00763000294328)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000294328), received between Jan 6, 2023 and Jun 17, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS LIQUID LEAKAGE WITH A BALLOON, TWO GUIDEWIRES COULD NOT EXIT THE DISTAL END OF THE BALLOON, ONE COIL WAS STRETCHED AND REPLACED WITH A PRODUCT OF THE SAME MODEL AND IMPLANTED SUCCESSFULLY, AND ANOTHER COIL COULD NOT BE DETACHED AND WAS SUCCESSFULLY IMPLANTED AFTER REPLACEMENT. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546963 ↗
• MalfunctionJun 13, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT ASSISTED EMBOLIZATION ANEURYSM SURGERY, CONTRAST AGENT LEAKED OUT DURING INFLATION. THE BALLOON WAS REPLACED AND THE SURGERY WENT SMOOTHLY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528682 ↗
• MalfunctionApr 2, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT ANEURYSM EMBOLIZATION WAS PERFORMED. AFTER THE BALLOON WAS IN PLACE, IT WAS INFLATED. LEAKAGE OF THE BALLOON WAS FOUND, ANOTHER BALLOON WAS REPLACED, FILLED SMOOTHLY, AND THE OPERATION WAS COMPLETED NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE BALLOON DID NOT INFLATE. THE LEAK WAS OBSERVED INSIDE THE BODY. IT WAS CLARIFIED THAT LIQUID WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020224 ↗
• MalfunctionMar 22, 2024Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE HYPERFORM BALLOON WAS FOUND TO BE DAMAGED DURING EXTRACORPOREAL INFLATING. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE BALLOON WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER BALLOON. THE PROCEDURE THAT WAS BEING PERFORMED WAS A BALLOON-ASSISTED COIL EMBOLIZATION. LEAKAGE WAS DISCOVERED WHEN THE BALLOON WAS INFLATED DURING THE SYSTEM PREPARATION IN VITRO. THE CAUSE OF THE DAMAGE WAS THE BALLOON WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961229 ↗
• MalfunctionJan 11, 2024Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER PREPARING THE HYPERFORM BALLOON, AND INSERTED IT INTO THE PATIENT, THE BALLOON DOES NOT INFLATE AS EXPECTED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NOT EXTENSIVE GUIDEWIRE MANIPULATION. A SYNCHRO GUIDEWIRE WAS USED. THE GUIDEWIRE TIP WAS REASONABLY ADVANCED OUT OF THE CATHETER TIP DURING INFLATION AND DEFLATION. THE PHYSICIAN DID NOT SHAPE THE GUIDEWIRE TIP. 50:50 CONTRAST WAS USED. A STEADY INJECTION RATE WAS USED. A SYRINGE STEADY INJECTION WAS USED TO DEFLATE THE BALLOON. AFTER MULTIPLE ATTEMPTS THE CATHETER AND GUIDEWIRE WERE REMOVED AND INSPECTED. NO CLOT WAS FOUND. NO BLOOD ENTERED THE CATHETER LUMEN. NO CONTRAST WAS OBSERVED LEAKING DURING INFLATION ATTEMPT. THERE WERE NO KINKS ON THE CATHETER DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491685 ↗
• MalfunctionSep 25, 2023Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN TESTED THE BALLOON PRIOR TO USE. THE BALLOON DID NOT PERFORM AS INTENDED DURING TESTING. THE GUIDEWIRE TIP ADVANCED ABOUT 4 CM OUT OF THE CATHETER TIP DURING THE INFLATION. DURING EXTERNAL INFLATING, WATER LEAKAGE WAS FOUND AT THE DISTAL MARK. THE PHYSICIAN SHAPED THE GUIDEWIRE TIP. THE BALLOON WAS INFLATED TWICE, BUT IT STILL LEAKED. THE INJECTION RATE WAS SLOW. AN ORDINARY SYRINGE (1 MM) WAS USED DURING INFLATION/DEFLATION OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807768 ↗
• MalfunctionJun 23, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED REPORTED THE LESION WAS IN THE OPHTHALMIC ARTERY. VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PRE PARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190905 ↗
• MalfunctionJun 6, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE HYPERFORM BALLOON WAS OPENED LIKE NORMAL. THE DOCTOR PREPPED THE DEVICE AND ATTACHED THE RHV <(>&<)> 3-WAY COMBO. THE CATHETER WAS ALSO FLUSHED BEFORE INSERTING THE WIRE. AFTER INSERTING THE WIRE AND WHILE ATTEMPTING TO PURGE THE BALLOON OF AIR, THE DOCTOR NOTICED THAT EVEN AFTER FLUSHING ROUGHLY 8CC OF CONTRAST MIX THE BALLOON WOULD NOT INFLATE. WE DETERMINED THAT THE DEVICE WAS DEFECTIVE AND WE REMOVED THE DEVICE FROM THE TABLE. WE OPENED ANOTHER HYPERFORM BALLOON AND FLUSHED THE DEVICE IN THE SAME MANNER AND THE NEW DEVICE WORKED AS INTENDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER WAS NEVER INSERTED INTO THE PATIENT AS THE BALLOON WAS NOT WORKING PROPERLY. THERE WAS NO EXTENSIVE GUIDEWIRE MANIPULATION, ONLY THE WIRE THAT COMES WITH THE BALLOON WAS PLACED IN THE DEVICE. THE WIRE WAS ESTIMATED TO BE ADVANCED APPROXIMATELY 2-3CM OUT THE TIP OF THE CATHETER. THE WIRE WAS NOT SHAPED YET AND THE CONTRAST RATIO WAS 50:50. THE INJECTION RATE WAS SLOW AND STEADY. THE BALLOON WAS NEVER INFLATED. BLOOD DID NOT ENTER THE CATHETER LUMEN. CONTRAST WAS OBSERVED LEAKING AND THE BALLOON WAS NEVER INFLATED. THERE WERE NO KINKS ON THE CATHETER DU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073665 ↗
• InjuryMay 3, 2023Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE HYPERFORM BALLOON POPPED UPON INFLATION IN THE INTERNAL CAROTID ARTERY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 16859890 ↗
• MalfunctionFeb 17, 2023Burst Container or Vessel; Physical Resistance/Sticking; Burst Container or Vessel; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE LEAKING WAS FOUND DURING THE PROCEDURE, BUT THEY WERE UNSURE WHERE THE LEAK POINT WAS. THE LEAK WAS VERIFIED OUTSIDE THE PATIENT. THERE WAS NO EXTENSION GUIDEWIRE MANIPULATION, AND A BALANCE MIDDLE WEIGHT GUIDEWIRE WAS USED. THE GUIDEWIRE WAS SAID TO BE FAR ENOUGH OUT FROM THE CATHETER TIP. THE GUIDEWIRE TIP WAS SHAPED. A 50:50 CONTRAST RATIO WAS USED. THE INJECTION RATE WAS SLOW AND STEADY. BLOOD DID NOT ENTER THE CATHETER LUMEN, AND THERE WAS NO CLOT AT THE TIP OF THE INFLATION HOLES. THE LEAK WAS SEEN ON THE BLANK ROADMAP, AND CONFIRMED ON THE REAL TIME FLUORO. THERE WAS NO KINK OR DAMAGE OBSERVED ON THE CATHETER OR GUIDEWIRE DURING USE. THE PHYSICIAN DID TEST THE BALLOON PRIOR TO USE, AND THERE WAS DIFFICULTY GETTING THE GUIDEWIRE OUT OF THE TIP. THERE WAS NO FRICTION OR DIFFICULTY DURING INFLATION. A 1 CC MEDALLION SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401528 ↗
• MalfunctionJan 6, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  MEDTRONIC RECEIVED REPORT THAT DURING THE PROCEDURE, WHEN THE DOCTOR PUT THE X-PEDION GUIDEWIRE THROUGH THE HYPERFORM BALLOON AND ATTEMPTED TO INFLATE, THE BALLOON DID NOT INFLATE AND DRIPS CAME OUT THE END OF THE BALLOON. THE DEVICE WAS REPLACED WITH ANOTHER HYPERFORM OF A DIFFERENT LOT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112878 ↗