HyperGlideTM 104-4127Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536005020), received between May 15, 2019 and May 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2019Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED INFORMATION THAT THE HYPERGLIDE BALLOON BURST DURING A PROCEDURE. PRIOR TO THE EVENT, THE PATIENT HAD JUST UNDERGONE A MECHANICAL THROMBECTOMY PROCEDURE AND A MIDDLE CEREBRAL ARTERY (MCA) STENOSIS WAS NOTICED UPON REMOVAL OF THE CLOT. THE PHYSICIAN WANTED TO ANGIOPLASTY THE STENOSIS BEFORE PLACING THE STENT. DURING THE ANGIOPLASTY, THE HYPERGLIDE BALLOON WAS INFLATED IN A VESSEL THAT WAS 1.7MM DISTAL AND 2.5MM PROXIMAL TO ITS NOMINAL SIZE AND THAT WAS WHEN THE REPORTED EVENT OCCURRED WITH THE BALLOON. THE BALLOON WAS, SUBSEQUENTLY, REMOVED FROM THE VESSEL WITH DIFFICULTY. UPON REMOVAL FROM THE BODY, THE BALLOON WAS BROKEN BY THE SCRUB TECHNICIAN TO ENSURE THAT THE WIRE HAD NOT BROKEN. THE BALLOON WAS TESTED PRIOR TO USE, AND IT PERFORMED AS INTENDED DURING TESTING. 10-15MM THE GUIDEWIRE TIP WAS ADVANCED OUT OF THE CATHETER TIP DURING THE INFLATION. THE CONTRAST RATIO WAS 50/50. ONLY ONE TIME THE BALLOON GET INFLATED AND DEFLATED. THE INJECTION RATE WAS STEADY. NON CADENCE, REGULAR 1ML SYRINGE WAS USED. THE PATIENT VESSEL WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient; Paresis

  MAUDE report 8612780 ↗