Provox Vega 22.5Fr 8mm 8284Recalls & reported problems
Atos Medical AB · Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791010880), received between Jul 8, 2024 and Jul 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Biofilm coating in Device” (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.
Reports received per month
Most reported problems
Device problems
- Biofilm coating in Device1
Patient problems
- Aspiration/Inhalation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2024Biofilm coating in Device; Biofilm coating in Device
OLD PROSTHESIS WAS REPLACED WITH A NEW PROSTHESIS ON (B)(6) 2024. PATIENT EXPERIENCED LEAKAGE THROUGH THE PROSTHESIS AFTER 2 DAYS OF REPLACEMENT. PATIENT & DOCTOR, BOTH WERE DEMANDING A FREE REPLACEMENT, SO WE HAVE PROVIDED A FREE REPLACEMENT ON (B)(6) 2024. ADDITIONAL QUESTIONS AND ANSWERS: HAS THE PATIENT USED A PROVOX VEGA PLUG TO SEAL THE LEAKAGE? ANSWER: PATIENT'S AND DOCTOR'S ARGUMENT WAS THAT, WHEN IT'S A NEW PROSTHESIS, THEN WHY SHOULD IT START LEAKING IN 2 DAYS ? BESIDES, WE HAVEN'T BEEN RECEIVING THE STOCK OF PROVOX VEGA PLUG FROM ATOS SINCE (B)(6) 2022. HOW SICK WAS THE PATIENT AFTER THE LEAKAGE, WAS HE FEELING NOT WELL OR DID HE DEVELOP A PNEUMONIA? ANSWER: PATIENT DIDN'T DEVELOP PNEUMONIA, BUT PATIENT WAS MENTALLY DISTURBED & PSYCHOLOGICALLY DEMOTIVATED BECAUSE HE HAD LOST WEIGHT SINCE HE WAS UNABLE TO TAKE ANY ORAL FEEDS. WHAT MEDICAL INTERVENTION WAS REQUIRED? ANSWER: PATIENT WAS ASPIRATING, SO WAS INSERTED WITH NG FEEDING TUBE. WHAT EFFECT DID IT HAVE ON THE PATIENT? ANSWER: PATIENT WAS FEELING BREATHLESS & WAS UNABLE TO TAKE ORAL FEEDS. HOW WAS THE PATIENT THEN AND HOW IS THE PATIENT TODAY? ANSWER: PATIENT WAS NOT KEEPING WELL THEN, BUT HE'S BETTER NOW AFTER NEW PR
Patient problems: Aspiration/Inhalation
MAUDE report 19687100 ↗
Other Prosthesis, Laryngeal (Taub) devices
- InHealth Technologies; Blom-Singer; Classic IN 1610-LFFreudenberg Medical, LLC · Prosthesis, Laryngeal (Taub)1 recall0 reports
- InHealth Technologies; Blom-Singer; Classic IN 1610-LEFFreudenberg Medical, LLC · Prosthesis, Laryngeal (Taub)1 recall0 reports
- Provox2 Voice Prosthesis 8mm 7218Atos Medical AB · Prosthesis, Laryngeal (Taub)5 reports
- Provox ActiValve Strong 6 mm 7161Atos Medical AB · Prosthesis, Laryngeal (Taub)3 reports
- Provox Vega 22.5Fr 6mm 8283Atos Medical AB · Prosthesis, Laryngeal (Taub)2 reports
- Provox Vega 17Fr 6mm 8271Atos Medical AB · Prosthesis, Laryngeal (Taub)2 reports
- Provox ActiValve Strong 4.5 mm 7160Atos Medical AB · Prosthesis, Laryngeal (Taub)2 reports
- Provox Vega 22.5Fr 10mm 8285Atos Medical AB · Prosthesis, Laryngeal (Taub)2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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