HyperGlide 104-4127Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000294410), received between May 15, 2024 and Dec 10, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING IN VITRO TESTING OF THE BALLOON, IT FAILED TO ACHIEVE A NORMAL OCCLUSION STATE; WATER LEAKAGE OCCURRED AT THE TIP. THE PRODUCT WAS REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT. THE PATIENT HAS A HISTORY OF HYPERTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767474 ↗
• MalfunctionMay 29, 2025Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE FIRST BALLOON BURST, SO WE REPLACED IT WITH THE SECOND ONE. THE SECOND ONE BURST AGAIN, SO WE REPLACED IT WITH THE THIRD ONE. THEN THE OPERATION WAS SUCCESSFULLY COMPLETED. THE CAUSE OF THE BURSTS WAS NOT DETERMINED. BECAUSE THE BALLOON HAD BEEN DISCARDED IT WAS UNCLEAR WHERE WAS THE BALLOONS' LEAK WAS. NO CARTRIDGE SYRINGES WERE USED, AND IT WAS UNCLEAR WHAT SYRINGES WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107004 ↗
• MalfunctionMay 29, 2025Burst Container or Vessel; Packaging Problem; Burst Container or Vessel; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A HOLE WAS DETECTED IN THE HYPERGLIDE BALLOON WHILE PREPPING. THE DEVICE NEVER WENT INTO THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105080 ↗
• MalfunctionMay 19, 2025Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE PACKAGE AND HYDRATING, THE BALLOON WAS FOUND TO BE LEAKING WATER. IT WAS REPLACED AND THE SURGERY WAS COMPLETED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042911 ↗
• MalfunctionDec 4, 2024Burst Container or Vessel; Deflation Problem; Inflation Problem; Burst Container or Vessel; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE INVOLVING THE HYPERGLIDE 4.0 X 20 MM 4 MM TIP SYSTEM, THE OCCLUSION BALLOON RUPTURED BEFORE REACHING ITS MAXIMUM VOLUME. THE BALLOON, INITIALLY INFLATED WITH A 1:1 CONTRAST AGENT AND ANTICOAGULANT WATER MIXTURE, SUDDENLY DEFLATED WHEN INFLATED TO THE STANDARD CAPACITY WITH A CARTRIDGE SYRINGE. ATTEMPTS TO REINFLATE THE BALLOON WITH THE SAME MIXTURE WERE UNSUCCESSFUL, AND IT WAS SUSPECTED TO HAVE BURST. UPON REMOVAL FROM THE BODY, THE BURST WAS CONFIRMED. THE PROCEDURE INVOLVED ADDRESSING A LEFT INTERNAL CAROTID CAVERNOUS FISTULA, WITH BILATERAL PUNCTURE PERFORMED. THE LEFT SIDE USED AN 8F 95CM GUIDING CATHETER, AND THE RIGHT SIDE USED A 6F 105CM JOHNSON & JOHNSON ENVOY DA. TWO ECHELON10S WERE USED, ONE FOR EMBOLIZATION COILS AND THE OTHER FOR GLUE INJECTION. AFTER THE INITIAL BALLOON FAILURE, A REPLACEMENT HYPERGLIDE-4-20 BALLOON OF THE SAME MODEL AND SIZE WAS USED, WHICH INFLATED SUCCESSFULLY AND EFFECTIVELY SEALED THE CAVERNOUS SINUS FISTULA. THE PROCEDURE CONTINUED WITH THE USE OF ECHELON 10 COILS, AXIUM-22-50-3D COILS, BRIDGE COILS, AND ONYX INJECTIONS, WITH ANGIOGRAPHYCONFIRMING THE COMPLETE BLOCKAGE OF THE FISTULA. THE BLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849230 ↗
• MalfunctionJul 10, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE HYPERGLIDE BALLOON CATHETER WAS FOUND LEAKING AND COULD NOT BE INFLATED, TWO ECHELON MICROCATHETERS ENCOUNTERED RESISTANCE, AND AN APOLLO CATHETER ENCOUNTERED RESISTANCE WITH THE MIRAGE GUIDE WIRE AND THE TIP BECAME DETACHED. THE PATIENT WAS UNDERGOING MINIMALLY INVASIVE NEURO-INTERVENTION FOR TREATMENT OF A DURAL ARTERIOVENOUS FISTULA. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 9 MM, THE RADIAL ARTERY WITH A DIAMETER OF 2.7 MM AND AN UNKNOWN VEIN WITH A DIAMETER OF 10 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE RADIAL ARTERY WAS PUNCTURED, AND THE BIOTECH 6F 90CM LONG SHEATH REACHED THE TARGET VESSEL FOR TREATMENT. THE HYPERGLIDE BALLOON WAS OPENED IN VITRO, HYDRATED, AND THEN INFLATED AND DEFLATED AS USUAL. HOWEVER, DURING THE INFLATION, IT WAS FOUND THAT THE BALLOON WAS LEAKING WATER AND COULD NOT BE INFLATED, AND THERE WAS ALSO WATER BACKFLOW AT THE PROXIMAL END OF THE BALLOON CATHETER. AFTER RE-HYDRATION, THE INFLATION AND DEFLATION IT WAS TRIED AGAIN, BUT THE PREVIOUS SITUATION STILL OCCURRED. IN DESPERATION, THE SURGEON DARED NOT USE THE PRODUCT AND REPORTED THE COMPLAINT. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712460 ↗
• MalfunctionMay 15, 2024Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT DURING A PIPELINE SURGERY, A BALLOON WAS USED FOR POST-PROCESSING. AFTER THE BALLOON WAS IN PLACE, A SYRINGE WAS USED TO EXPAND IT NORMALLY. AFTER EXPANSION, IT WAS FOUND THAT THE BALLOON WAS LEAKING AND DAMAGED, SO THE BALLOON WAS REPLACED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325274 ↗