InnoVoyce LLC ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860004755913), received between Jun 7, 2023 and Jun 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 7, 2023Material Integrity Problem; Material Integrity Problem

  INNOVOYCE RECEIVED A CUSTOMER REPORT OF A PRODUCT PROBLEM WITH THE .600 KTP FIBER, WHERE THE FIBER "BROKE OFF INSIDE A PATIENT" DURING A ROUTINE PROCEDURE. THE PHYSICIAN RETRIEVED THE PIECE OF FIBER FROM THE PATIENT AND THE PATIENT WAS INTUBATED AS A PRECAUTION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083624 ↗