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Provox ActiValve Strong 8 mm 7162Recalls & reported problems

Atos Medical AB · The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791000591), received between Dec 2, 2016 and Dec 2, 2016.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • Dec 2, 2016Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

    THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE ATOS MEDICAL LOCAL REPRESENTATIVE: "PT. CALLED SLP TO REPORT THAT HER VOICE PROSTHESIS CAME OUT WHEN SHE WAS CLEANING IT. PT. HAS VISION PROBLEMS AND HAD A PROCEDURE EARLIER IN THE WEEK TO INJECT HER EYES. HER VISION WORSENED AFTER THIS PROCEDURE. PT. PULLED PROSTHESIS OUT OF PUNCTURE WITH VIGOROUS CLEANING. PT. REPORTED THAT DURING CLEANING, SHE FELT THE BRUSH WAS GETTING STUCK SO SHE PULLED HARDER. SHE ASPIRATED PROSTHESIS AND COUGHED IT BACK OUT IMMEDIATELY. SHE WENT TO CLINICIAN FOR REPLACEMENT OF PROSTHESIS. SLP INSTRUCTED PT IN THE USE OF LUBRICANT IMMEDIATELY AFTER DEVICE WAS INITIALLY PLACED BUT PT REVIEWED THE PATIENT IFU IN CLINIC AND VOICED HER CONCERNS RE: PNEUMONIA AND SAID SHE WOULD THINK ABOUT USING THE LUBRICANT WHILE AT SLP OFFICE AFTER DISLODGEMENT, PT. REPORTED THAT SHE HAD NOT BEEN APPLYING THE LUBRICANT TO THE ACTIVALVE PROSTHESIS (EVEN WITH A BRUSH) BECAUSE SHE READ THE WARNINGS IN THE PATIENT IFU NOT TO APPLY FROM THE BOTTLE DIRECTLY BECAUSE IT MAY CAUSE PNEUMONIA. SHE CHOSE NOT TO LUBRICATE AT ALL. SLP REPORTS THAT, PRIOR TO DISLODGEMENT, PT. HAD COMPLAINED TO SLP THAT THE PROSTHESIS WAS "TOO DIFFICULT TO US

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6141070 ↗

Other Prosthesis, Laryngeal (Taub) devices

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Sources and updates

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