Provox ActiValve Light 6 mm 7151Recalls & 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 07331791000539), received between Mar 20, 2017 and Mar 20, 2017 — classified as 1 malfunction.
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.
MalfunctionMar 20, 2017Improper 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: WHEN THE DOCTOR INSERTED THE ACTIVALVE WITH THE PATIENT, THE ENTIRE BLUE INSIDE (INCLUDING THE VALVE) LET LOOSE AND FELL. THE DOCTOR COULD REACH FOR IT WITH A TWEEZER, BEFORE IT HAD A CHANCE TO FELL INTO THE PATIENT LUNGS. OUR PRODUCT SPECIALIST WAS THERE AND WATCHED THE INSERTION AND EVERYTHING WAS DONE ACCORDING THE IFU. THEY HAD TO MAKE A CT SCAN AND MRI, TO CHECK WHERE HIS PREVIOUS VOICE PROSTHESIS WAS (PROBABLY SWALLOWED IT), SO THEY COULD IMMEDIATELY CHECK IF REALLY NOTHING FELL INTO THE LUNGS. AFTER THIS ANOTHER ACTIVALVE WAS PLACED AND THERE WERE NO PROBLEMS. DEVICE HAS BEEN RETURNED AND INVESTIGATED. (B)(6) 2017
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6416662 ↗
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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