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HyperFormTM 104-4370Recalls & reported problems

Micro Therapeutics, Inc. · 104-4370 HYPERFORM 3X7MM BALLOON SYS · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536005358), received between Oct 7, 2019 and Oct 7, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Deflation Problem” (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

  • Deflation Problem1

Patient problems

  • Death1
  • Hemorrhage, Subarachnoid1

Recent adverse event reports

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

  • DeathOct 7, 2019Deflation Problem; Deflation Problem

    ADDITIONAL INFORMATION WAS RECEIVED: THE PATIENT'S ANATOMY WAS REPORTEDLY "NOT MORE THAN USUAL." THE PHYSICIAN REPORTED THAT AFTER THE HYPERFORM FAILED TO DEFLATE, HE REALIZED BLOOD HAD ENTERED THE BALLOON LUMEN AND HAD INJECTED TPA AS WELL AS HEPARINIZED SALINE IN AN ATTEMPT TO BREAK UP THE BLOOD. THESE DEFLATION ATTEMPTS WERE NOT SUCCESSFUL. IT WAS REPORTED THAT THE PATIENT PASSED AWAY 3-4 DAYS POST-PROCEDURE.

    Patient problems: Death; Hemorrhage, Subarachnoid

    MAUDE report 9163261 ↗

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.