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Gyrus ACMI 140187Recalls & reported problems

Gyrus ACMI, LLC · HOUSE-TYPE SS WIRE LP · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925015494), received between Jul 14, 2022 and Jul 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

Patient problems

  • Unspecified Ear or Labyrinth Problem1

Recent adverse event reports

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

  • InjuryJul 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

    THE CUSTOMER REPORTS A PATIENT CONTACTED THEM AND STATES THAT THE MRI COMPLETED AT THEIR FACILITY WHILE HIS HOUSE-TYPE SS WIRE LP WAS IMPLANTED CAUSED A DISLODGEMENT OF THE WIRE REQUIRING A SURGICAL PROCEDURE TO REPLACE IT. THE CUSTOMER STATES THE MAGNETIC FLUX DENSITY OF THE MRI MACHINE USED AT THEIR FACILITY IS 1.5 TESLAS. THE CUSTOMER FURTHER STATES THAT THE RADIOLOGY SAFETY PHYSICIAN FOR THE FACILITY HAS REVIEWED THIS PATIENTS CASE AND FEELS IT IS VERY UNLIKELY THAT THE MRI COULD HAVE DISLODGED THE IMPLANTED WIRE (AT THIS MAGNETIC FLUX DENSITY LEVEL).

    Patient problems: Unspecified Ear or Labyrinth Problem

    MAUDE report 15019419 ↗

Other Prosthesis, Partial Ossicular Replacement devices

All Prosthesis, Partial Ossicular Replacement devices →

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