HyperGlide 104-4112Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000294359), received between Jul 10, 2023 and Jun 11, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN TESTED THE BALLOON INFLATION BEFORE USING IT ON THE PATIENT AND FOUND THAT THE BALLOON WAS LEAKING AND COULD NOT BE FULLY INFLATED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183975 ↗
• MalfunctionFeb 18, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED REPORTED THE BALLOON LEAK WAS OBSERVED DURING INTRAOPERATIVE USE, EXTRACORPOREAL INFLATION. THE PATIENT WAS BEING TREATED FOR AN IRREGUALR ANEURSYM. VESSEL TORTUOSITY WAS MILD. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIOSN FOR USE (IFU. THE BALLOON WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NOT EXTENISVE GUIDEWIRE MANIPULATION. DURING INFLATION THE GUIDEWIRE TIP WAS NOT ADVANCED OUT OF THE CATHETER TIP. THE INJECTION RATE WAS SLOW. AFTER MULTIPLE INFLATIONS THE CATHETER AND GUIDEWIRE WAS REMOVED AND INSPECTED. THE HEALTHCARE PROVIDER (HCP) DID NOT VERIFY THE PERFORMANCE OF THE BALLOON AND INSPECT FOR PRESENCE OF CLOT AT THE TIP OR INFLATION HOLES. BLOOD DID NOT ENTER THE CATHETER LUMEN. CONTAST WAS NOT OBSERVED LEAKING DURING THE INFLATION ATTEMPT. THERE WERE NO KINKS ON THE CATHETER DURING USE. THE HCP TESTED THE BALLOON PRIOR TO USE. THE BALLOON DID NOT PERFORM AS INTENDED DURING TESTING. THE BALLOON LEAK WAS AT THE TIP. A 1ML SYRINGE WAS USED DURING INFLATION/DEFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393275 ↗
• MalfunctionAug 23, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION THAT A HYPERGLUIDE BALLOON WAS LEAKING. THE BALLOON LEAKED LIQUID. AFTER REPLACING IT, IT WAS USED SMOOTHLY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. THE DEVICE PREPARED AS INDICATED IN THE IFU. THE CAUSE OF THE BALLOON LEAK WAS NOT DETERMINED. THE MATCHING GUIDEWIRE WAS USED WITH THE BALLOON. THE GUIDEWIRE TIP WAS UNSHAPED. THE GUIDEWIRE WAS ABOUT 3CM FROM THE CATHETER TIP DURING INFLATION/DEFLATION. THE PHYSICIAN DID TEST THE BALLOON PRIOR TO USE. THE BALLOON DID PERFORM AS INTENDED DURING TESTING. THE CONTRAST RATIO WAS 50/50. THE INJECTION RATE WAS STEADY. A CARTRIDGE SYRINGE WAS USED DURING INFLATION/DEFLATION OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20051214 ↗
• MalfunctionJan 12, 2024Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT FOR A LARGE ANEURYSM OF THE C4 SEGMENT OF THE INTERNAL CAROTID ARTERY, 18-20MM, THE PHYSICIAN USED THE OCCLUDING BALLOON CATHETER SYSTEM TO ASSIST EMBOLIZATION. AFTER THE OCCLUDING BALLOON CATHETER SYSTEM WAS PLACED IN PLACE, THE BALLOON COULD NOT BE INFLATED AND THEN WITHDREW FROM THE BODY. IT ALSO COULD NOT BE INFLATED OUTSIDE THE BODY.  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 18502796 ↗
• MalfunctionJul 10, 2023Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE LEAK WAS UNKNOWN. THERE WAS NO OBVIOUS DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290604 ↗