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HyperGlideTM 104-4112Recalls & reported problems

Micro Therapeutics, Inc. · 104-4112 HYPERGLIDE 4X15MM BALLOON SYS · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536004863), received between Mar 2, 2020 and Mar 2, 2020 — 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

Device problems

  • Burst Container or Vessel1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMar 2, 2020Burst Container or Vessel; Burst Container or Vessel

    MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX WITH SHIELD DEVICE DID NOT OPEN AT THE PROXIMAL SECTION. THE HYPERGLIDE BALLOON WAS SELECTED TO OPEN THE PIPELINE DEVICE. HOWEVER, THE BALLOON RUPTURED DURING THE INFLATION. A NEW BALLOON WAS USED TO OPEN THE PIPELINE DEVICE. NO PATIENT INJURY OCCURRED. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY. THE PIPELINE WAS PLACE IN A CURB / BEND IN THE ANATOMY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9774241 ↗

Other Catheter, intravascular occluding, temporary devices

All Catheter, intravascular occluding, temporary devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.