HyperForm 104-4470 (UDI 00763000294267)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000294267), received between Jul 31, 2023 and Nov 19, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VESSEL TORTUOSITY WAS NORMAL. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU (INSPECTION ,HYDRATION, ETC.). THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. LEAKAGE OCCURRED DURING SET UP. THE ISSUE WAS DISCOVERED DURING IN VITRO TESTING. THE CAUSE OF THE LEAK WAS NOT DETERMINED. THE BALLOON PERFORMED AS INTENDED DURING TESTING. THE GUIDEWIRE TIP WAS ADVANCED 7CM OUT OF THE CATHETER TIP DURING THE INFLATION. BALLOON LEAK WAS AT THE TIP. THE PHYSICIAN DID NOT SHAPE THE GUIDEWIRE TIP. THE BALLOON WAS INFLATED AND DEFLATED 1 TIME. INJECTION RATE WAS SLOW. A 1ML SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593894 ↗
• MalfunctionNov 11, 2025Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 9 MM AND A 5 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS STRETCHED AND REPLACED AND THEN THE NEW COIL WAS IMPLANTED SMOOTHLY. AFTER THE ECHELON MICROCATHETER WAS SHAPED, IT WAS FOUND THAT THE TIP OF THE MICROCATHETER WAS DAMAGED. AFTER REPLACEMENT, THE OPERATION WAS SUCCESSFULLY COMPLETED. THE GUIDEWIRE COULD NOT PASS THROUGH THE ECHELON MICROCATHETER, AND THE OPERATION WAS SUCCESSFUL AFTER IT WAS REPLACED; THE GUIDEWIRE WAS OF ANOTHER BRAND. DURING HYPERFORM BALLOON PREPARATION, AIR LEAKAGE WAS DETECTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE 2 ECHELON CATHETERS, A HYPER FORM BALLOON AND AN ADDITIONAL AXIUM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525971 ↗
• MalfunctionJul 21, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE BALLOON WAS PRE-FILLED IN VITRO, LEAKED AIR, AND THE OPERATION WAS SUCCESSFULLY COMPLETED AFTER REPLACEMENT. IT WAS UNKNOWN WHETHER THE REPORTED DEVICE 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 22555804 ↗
• MalfunctionSep 13, 2024Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED ANEURYSM OF THE LEFT ANTERIOR COMMUNICATING ARTERY, 3.8-2.6MM. VESSEL TORTUOSITY WAS MODERATE. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE CAUSE OF THE BALLOON BURST WAS NOT DETERMINED. THE PHYSICIAN DID NOT TEST THE BALLOON PRIOR TO USE. BALLOON LEAK OCCURRED IN THE MIDDLE SECTION. THE PHYSICIAN DID NOT SHAPE THE GUIDEWIRE TIP. THE BALLOON WAS INFLATED AND DEFLATED 2 TIMES. THE INJECTION RATE WAS STEADY. A CARTRIDGE SYRINGE WAS USED DURING INFLATION/DEFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211947 ↗
• MalfunctionJun 19, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT WHEN USING THE HYPERFORM BALLOON, AIR LEAKAGE WAS FOUND WHEN VENTING OUTSIDE THE BODY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT WHEN THE BALLOON WAS DEFLATED OUTSIDE THE BODY, CONTRAST AGENT WAS FOUND TO HAVE LEAKED OUT. THERE WAS NO GUIDEWIRE OPERATIONS. AN XPEDION GUIDEWIRE WAS USED WITH THE BALLOON. DURING THE INFLATION, THE GUIDEWIRE TIP WAS ADVANCED OUT OF THE CATHETER TIP ABOUT 1 CM. THE PHYSICIAN DID SHAPE THE GUIDEWIRE TIP. CONTRAST AGENT AND SALINE 1:1 RATIO. THE INJECTION RATE WAS STEADY. THE METHOD USED TO DEFLATE THE BALLOON WAS WITHDRAWAL WITH A SYRINGE. THERE WERE NOT MULTIPLE INFLATIONS, AND CONTRAST AGENT LEAKAGE WAS FOUND DURING THE FIRST INFLATION. BLOOD DID NOT ENTER THE CATHETER LUMEN AS THE BALLOON DID NOT ENTER THE PATIENT. CONTRAST WAS OBSERVED LEAKING DURING THE INFLATION ATTEMPT. THERE WERE NO KINKS ON THE CATHETER DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570525 ↗
• MalfunctionJul 31, 2023Leak/Splash; Physical Resistance/Sticking; Leak/Splash; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED LESION CHARACTERISTICS: GIANT MALFORMATION AVM FAR FROM M2. VESSEL TORTUOSITY WAS MODERATE. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PROCEDURE COMPLETED WITH A NEW BALLOON. THE GUIDEWIRE TIP WAS ADVANCED OUT OF THE CATHETER TIP DURING THE INFLATION. THE PHYSICIAN SHAPED THE GUIDEWIRE TIP. THERE WAS NO KINK OR DAMAGE ON THE GUIDEWIRE. THE GUIDEWIRE WAS ABLE TO PASS THE CATHETER HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424135 ↗