Provox2 Voice Prosthesis 10mm 7219Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791010071), received between Feb 21, 2025 and Feb 21, 2025 — classified as 1 death.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• DeathFeb 21, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THIS IS A CASE REPORT DESCRIBED IN THE LITERATURE PUBLICATION: YOHAN SONG, KRISTA KIYOSAKI, EDWARD J. DAMROSE, EPIDURAL ABSCESS AND PARAPLEGIA: DELAYED SEQUELA OF TRACHEOESOPHAGEAL PUNCTURE, OTOLARYNGOLOGY CASE REPORTS, VOLUME 5, 2017, PAGES 21-23, ISSN 2468-5488, HTTPS://DOI.ORG/10.1016/J.XOCR.2017.10.002. (HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S2468548817301388). THIS CASE REPORT WAS IDENTIFIED DURING A LITERATURE SEARCH FOR VOICE PROSTHESES CONDUCTED IN ACCORDANCE WITH THE PERIODIC UPDATE OF THE CLINICAL EVALUATION REPORT. THE CASE DESCRIBES A 78-YEAR OLD FEMALE WHO HAD TOTAL LARYNGECTOMY AND PRIMARY PLACEMENT OF A 10 MM PROVOX2 IN OCTOBER 2016. FOUR MONTHS LATER SHE WAS BROUGHT TO THE EMERGENCY DEPARTMENT WITH FOR A TWO-DAY HISTORY OF PROGRESSIVE BILATERAL LOWER EXTREMITY WEAKNESS AND SUBSEQUENT FALL. MR IMAGING OF THE CERVICAL AND THORACIC SPINE SHOWED AN EPIDURAL ABSCESS. THE IMAGING WAS HIGHLY SUSPICIOUS FOR EROSION OF THE VOICE PROSTHESIS THROUGH THE POSTERIOR ESOPHAGUS AT THE LEVEL OF THE ABSCESS. SHE HAD AN OPERATION TO REMOVE THE ABSCESS. POST-OPERATIVELY, THERE WAS NO OBVIOUS PROJECTION OF THE DEVICE THROUGH THE POSTERIOR ESOPHAGUS, AS WAS EXPECTED BY THE IM

  Patient problems: Abscess; Osteomyelitis; Sepsis

  MAUDE report 21430394 ↗