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HyperFormTM 104-4415Recalls & reported problems

Micro Therapeutics, Inc. · 104-4415 HYPERFORM 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 00847536005419), received between Jul 25, 2019 and Jul 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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

  • Leak/Splash1

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.

  • MalfunctionJul 25, 2019Leak/Splash; Leak/Splash

    MEDTRONIC RECEIVED INFORMATION THAT DURING PREPARATION, THE BALLOON COULD NOT PROPERLY INFLATE OR DEFLATED DUE TO PROBLEMS WITH THE TIP SEALING THE BALLOON COMPLETELY. DURING INFLATION, THE TIP OF THE GUIDEWIRE WAS ADVANCED 10CM FROM THE END OF THE CATHETER. THE LEAK OCCURRED AT THE DISTAL GUIDEWIRE TIP. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8828935 ↗

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.