HyperForm 104-4415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000294205), received between Feb 22, 2023 and Jul 14, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE BALLOON RUPTURED. DURING PROCEDURE, WAS THERE NOT EXTENSIVE GUIDEWIRE MANIPULATION. ITS OWN GUIDEWIRE X-PEDION WAS USED WITH THE BALLOON. DURING THE INFLATION, THE GUIDEWIRE TIP ADVANCED 10CM OUT OF THE CATHETER TIP. THE GUIDEWIRE TIP WAS NOT SHAPED. 50:50 CONTRAST RATIO WAS USED. THE INJECTION RATE WAS SLOW. WITHDREW THE GUIDEWIRE TO DEFLATE THE BALLOON. IT WAS NOT INFLATED MULTIPLE TIMES. BLOOD DID NOT ENTER THE CATHETER LUMEN. CONTRAST AGENT LEAKAGE WAS FOUND. THE CATHETER WAS NOT KINKED. THE BALLOON WAS TESTED IN VITRO. THE BALLOON PERFORMED AS INTENDED. A CARTRIDGE SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493401 ↗
• MalfunctionFeb 22, 2023Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS A PATIENT WITH RECURRENT NASOPHARYNGEAL CARCINOMA. A BALLOON OCCLUSION EXPERIMENT WAS PERFORMED IN THE LEFT INTERNAL CAROTID ARTERY, AND 6F GUIDING WAS USED AS THE PROXIMAL SUPPORT CATHETER. AFTER THE HYPERFORM BALLOON WAS HYDRATED IN VITRO, IT WAS DEFLATED AND PRE-FILLED. WHEN THE X-PEDION-10 GUIDE WIRE CAME OUT OF THE DISTAL END OF THE BALLOON, THERE WAS A STUCK. THE GUIDE WIRE CAME OUT ABOUT 2 CM FROM THE TIP OF THE BALLOON CATHETER, AND THE SURGEON INFLATED THE BALLOON WITH A CARTRIDGE SYRINGE, BUT FOUND THE TIP OF BALLOON LEAKED WATER, AND THE BALLOON COULDN'T BE INFLATED. THE SURGEON SAID THAT THE BALLOON HAD QUALITY PROBLEMS AND DID NOT CHARGE FOR IT, AND REQUESTED A REPORT FOR DAMAGE TESTING. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416571 ↗