Provox XtraFlange 22.5 7275Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791006920), received between Jun 5, 2019 and Jun 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionJun 5, 2019Use of Device Problem; Material Fragmentation; Use of Device Problem; Device Dislodged or Dislocated

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: PROVOX XTRA FLANGE 22.5FR WAS PLACED ON (B)(6) 2019 IN CLINIC, WHILE ON ZOOM WITH A CLINICAL REP FROM ATOS. WHEN THE PATIENT WOKE UP ON 5/10, THE XTRA FLANGE HAD DISLODGED. HE CONTACTED HIS CLINICIAN AROUND 9AM, STATING HE WAS CLEANING HIS PROSTHESIS AND STARTED COUGHING. HE NOTICED THAT THERE WAS A "WHITE PIECE" IN HIS AIRWAY WHICH HE THEN WAS ABLE TO REMOVE WITH HIS BLUE BRUSH. PATIENT DENIES MANIPULATING THE XTRA FLANGE; HOWEVER, HE DID NOTE A VERY TIGHT FIT OF HIS LARYTUBE WHEN PLACING THE PREVIOUS NIGHT. DESCRIPTION OF THE PRODUCT: PROVOX XTRA FLANGE 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 8669649 ↗