Provox XtraFlange 20 7276Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791006937), received between Nov 26, 2019 and Nov 26, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device 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 18, 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.

• MalfunctionNov 26, 2019Use of Device Problem; Use of Device Problem

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: CLINICIAN REPORTED THAT PATIENT WAS SEEN IN CLINIC. PATIENT REPORTS HE COUGHED FORCEFULLY AND BELIEVES XTRAFLANGE DISLODGED. XTRAFLANGE WAS NOT LOCATED BY PATIENT. CLINICIAN ORDERED CHEST X-RAY, HOWEVER, AWARE THAT XTRAFLANGE IS NOT RADIOPAQUE. PATIENT ASYMPTOMATIC. PROSTHESIS WAS NOTED TO HAVE BIOFILM ON TRACHEAL FLANGE WHICH CAUSED FLANGE TO BE SLIGHTLY CURVED INWARD. DESCRIPTION OF THE PRODUCT: PROVOX XTRAFLANGE IS A SILICONE WASHER INTENDED TO REDUCE PERIPROSTHETIC LEAKAGE THAT IS DETECTED ON PATIENTS USING INDWELLING PROVOX VOICE PROSTHESES. PLACEMENT IS PERFORMED BY A MEDICAL DOCTOR OR A TRAINED MEDICAL PROFESSIONAL IN ACCORDANCE WITH LOCAL OR NATIONAL GUIDELINES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375024 ↗