Provox Vega 17Fr 6mm 8271Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07331791010750), received between Jun 14, 2019 and Feb 20, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FROM THE INITIAL PLACEMENT OF THE VOICE PROSTHESIS, THE PATIENT HAD AN UNCOMFORTABLE LEAK THAT TURNED INTO A TERRIFYING LEAK, INCLUDING BOTH LIQUID AND FOOD PARTICLES. THE PATIENT HAS ASPIRATED LIQUID AND FOOD PARTICLES INTO THE LUNGS AND MEDICAL PROFESSIONALS WERE CONCERNED THAT THE PATIENT COULD GET ASPIRATED PNEUMONIA IF HE/SHE CONTINUED TO USE THE VOICE PROSTHESIS. THE PATIENT WERE AT TIMES WORRIED THAT THE LEAKAGE WAS LIFE-THREATENING SINCE A LOT OF FLUID ENTERED THE LUNGS AND THE PATIENT COULD NOT TAKE A BREATH DEEP ENOUGH TO COUGH. 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 PROSTHESIS IS AVAILABLE IN DIFFERENT DIAMETERS AND SEVERAL LENGTHS AND IS MADE OF MEDICAL GRADE SILICONE RUBBER AND FLUOROPLASTIC. THE VOICE PROSTHESIS IS SEATED IN A PUNCTURE IN THE WALL BETWEEN ESOPHAGUS AND TRACHEA. INTENDED USE: PROVOX VEGA VOICE PROSTHESIS IS A STERILE SINGLE USE INDWELLING VOICE PROSTHESIS INTENDED FOR VOICE REHABILITATION AFTER SUR

  Patient problems: Aspiration/Inhalation

  MAUDE report 18736540 ↗
• MalfunctionJun 14, 2019Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem; Detachment of Device or Device Component

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: THE VOICE PROSTHESIS WOULD NOT STAY ON INSERTION STICK. WHEN ATTEMPTING TO PLACE THE VOICE PROSTHESIS IT CAME OFF THE STICK AND WHEN PATIENT TOOK A DEEP BREATH TO COUGH THE TAIL OF THE VOICE PROSTHESIS CAME OFF THE STICK AND THE PATIENT INHALED THE VOICE PROSTHESIS INTO HIS TRACHEA. PATIENT COUGHED IT RIGHT BACK UP AND WAS UNAFFECTED. SLP FELT THE STICK WAS NOT SIZED CORRECTLY FOR THE VOICE PROSTHESIS. DESCRIPTION OF THE PRODUCT: THE PROVOX VEGA VOICE PROSTHESIS IS A STERILE SINGLE USE INDWELLING VOICE PROSTHESIS INTENDED FOR VOICE REHABILITATION AFTER SURGICAL REMOVAL OF THE LARYNX (LARYNGECTOMY). THE PROVOX INSERTION SYSTEM IS A STERILE SINGLE USE DEVICE INTENDED FOR ANTEROGRADE REPLACEMENT OF THE PROVOX VEGA VOICE PROSTHESIS. THIS REPLACEMENT PROCEDURE IS CARRIED OUT BY A MEDICAL PROFESSIONAL IN ACCORDANCE WITH LOCAL OR NATIONAL GUIDELINES. THE PROVOX INSERTION SYSTEM IS NOT INTENDED TO BE USED FOR INSERTION OF A VOICE PROSTHESIS IN A FRESHLY MADE PUNCTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8699524 ↗