HyperGlide 104-4310Recalls & reported problems
Micro Therapeutics, Inc. · BALLOON SYSTEM 104-4310 V20 HYPERGLIDE · 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 00763000294472), received between May 29, 2025 and May 29, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 22106992 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.