Provox2 Voice Prosthesis 6mm 7217Recalls & reported problems
Atos Medical AB · Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device. · 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 07331791010033), received between Mar 17, 2020 and Mar 17, 2020 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
Patient problems
- Necrosis1
- Tissue Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: CLINICAL AFFAIRS WITHIN ATOS MEDICAL AB DID AN EXPANDED SEARCH DURING REGULAR CER UPDATE AND FOUND A CASE STUDY IN INDIA REGARDING PROVOX2. THE CASE STUDY WAS ABOUT A PATIENT THAT HAD A TOO SHORT PROSTHESIS FITTED, WHICH RESULTED IN PRESSURE NECROSIS OF THE PART WALL AND MUCOSA BETWEEN THE FLANGES. CASE STUDY: ANAM JR, KANNAN S, CHAUKAR DA, D'CRUZ A K. A RARE CASE OF TRACHEOESOPHAGEAL PUNCTURE WITH PARTY WALL NECROSIS. INDIAN J CANCER. 2015 JUL-SEP;52(3):303-4. INTENDED USE AND DESCRIPTION OF THE PRODUCT: THE PROVOX 2 VOICE REHABILITATION SYSTEM IS INTENDED FOR USE IN SURGICAL, PROSTHETIC VOICE RESTORATION AFTER TOTAL LARYNGECTOMY. THE PROSTHESIS MAY BE INSERTED BY THE PHYSICIAN AT THE TIME OF THE TOTAL LARYNGECTOMY (PRIMARY PUNCTURE), OR AT A LATER DATE (SECONDARY PUNCTURE), OR MAY BE USED TO REPLACE THE PRESENT PROSTHESIS. THE PROVOX2 VOICE PROSTHESIS IS A STERILE SINGLE USE ONE-WAY VALVE THAT KEEPS A TE-PUNCTURE OPEN FOR SPEECH, WHILE REDUCING THE RISK OF FLUIDS AND FOOD ENTERING THE TRACHEA. IT IS MADE OF MEDICAL GRADE SILICONE RUBBER AND RADIO-OPAQUE FLUOROPLASTIC. THE PROSTHESIS IS NOT A PERMANENT IMPLANT AN
Patient problems: Necrosis; Tissue Damage
MAUDE report 9841209 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page