HyperForm 104-4420Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000294236), received between Dec 8, 2023 and Aug 31, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519967 ↗
• MalfunctionFeb 10, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED A SELF-CONTAINED GUIDEWIRE WAS USED. THE GUIDEWIRE WAS ADVANCED 1 CM OUT OF THE CATHETER TIP. THE GUIDEWIRE TIP WAS NOT SHAPED. THE INJECTION RATE WAS STEADY. USED CARTRIDGE SYRINGE TO ASPIRATE OUT AND DEFLATE BALLOON. THE GUIDEWIRE WAS 7MM FROM THE CATHETER TIP DURING INFLATION/DEFLATION. AFTER MULTIPLE INFLATIONS, THE CATHETER AND GUIDEWIRE EAS NOT REMOVED OR INSPECTED. BLOOD DID NOT ENTER THE CATHETER LUMEN. CONTRAST WAS OBSERVED LEAKING DURING THE INFLATION ATTEMPT. THE CATHETER WAS NOT KINKED. THE PHYSICIAN TESTED THE BALLOON PRIOR TO USE.THE BALLOON DID NOT PERFORM AS INTENDED DURING TESTING. THE BALLOON LEAK WAS AT THE TIP, CONTRAST RATION WAS 50/50. THE BALLOON GAT INFLATED AND DEFLATED 3 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344643 ↗
• MalfunctionApr 18, 2024Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED INFORMATION THAT A BALLOON CATHETER WAS LEAKING AND BURST. THIS PATIENT HAD AN ARTERIOVENOUS FISTULA IN THE CAVERNOUS SINUS SEGMENT. USING 6FGUIDING AS PROXIMAL SUPPORT, THE ECHELON MICROCATHETER WAS PLACED INTO THE FISTULA OPENING. AFTER FILLING THE COIL, THE INTERNAL CAROTID ARTERY WAS BLOCKED WITH THE OCCLUSION BALLOON FOR ONYX EMBOLIZATION. AFTER THE BALLOON WAS HYDRATED OUTSIDE THE BODY, IT WAS DEFLATED AND PRE-INFLATED. THE X-PEDION-10 GUIDEWIRE GUIDED THE BALLOON TO THE C4 SEGMENT. THE GUIDE WIRE CAME OUT ABOUT 2CM FROM THE TIP OF THE BALLOON CATHETER. AFTER INSERTING 0.25CC WITH A CARTRIDGE SYRINGE, IT WAS FOUND THAT THE CONTRAST AGENT HAD LEAKED OUT. AFTER IT WAS WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE BALLOON HAD BURST. AFTER THE BALLOON WAS REPLACED, THE OPERATION WENT SMOOTHLY.  NO PATIENT SYMPTOMS OR COMPLICATIOSN WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139669 ↗
• MalfunctionDec 8, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS CLARIFIED THERE WAS BALLOON RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18294994 ↗