Provox Vega XtraSeal 17Fr 8mm 8290Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791010941), received between Sep 18, 2023 and Sep 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction 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.

• InjurySep 18, 2023Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  ENT PHYSICIAN REACHED OUT TO TSM MICHAEL MACKINNON FOR ASSISTANCE ON AN PROVOX VEGA XTRASEAL 17FR, 8MM. VOICE PROSTHESIS (VP) THAT WAS EMBEDDED IN THE PARTIES WALL TISSUE ALONG WITH POSTERIOR TRACHEAL WALL. HCP THEN CONTACTED CLINICAL EDUCATION (CE) TEAM ON 8/23 FOR ASSISTANCE. HCP WANTED TO HAVE VIRTUAL ASSISTANCE FROM THE CE IN THE OPERATION ROOM. 2 CE'S WORKED WITH THE ENT IN THE OPERATION ROOM. SAW THAT THE ANTERIOR FLANGE WAS EMBEDDED IN THE POSTTRIAL TRACHEAL WALL. ONLY THE CENTER LUMEN WAS VISIBLE. THE HCP DID NOT HAVE MANY OF THE ADEQUATE TOOLS TO REMOVE THE VP POSTERIORLY. EVENTUALLY DID GET THE VP OUT IN A RETROGRADE FASHION THROUGH THE ESOPHAGUS AND ORAL CAVITY. HCP PLACED RED RUBBER CATHETER AS THEY WERE UNABLE TO PLACE THE VP (3 ATTEMPTS FROM ASSISTANT AND HCP IN THE OR). PT WILL RETURN TO CLINIC 9/1 AND THE CE WILL BE ONSITE TO ASSIST WITH VP PLACEMENT IN THE OFFICE. DESCRIPTION OF THE PRODUCT: PROVOX VEGA AND PROVOX VEGA XTRASEAL ARE A ONE-WAY VALVE (PROSTHESES) THAT KEEPS A TE-PUNCTURE OPEN FOR SPEECH, WHILE REDUCING THE RISK OF FLUIDS AND FOOD ENTERING THE TRACHEA. PROVOX VEGA VOICE PROSTHESES ARE NOT PERMANENT IMPLANTS, AND NEEDS PERIODIC REPLACEMENT. THE PROSTHES

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 17764057 ↗