Provox ActiValve Strong 4.5 mm 7160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07331791000577), received between Mar 17, 2022 and Mar 19, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryMar 19, 2022Device Fell

  THIS IS THE EVENT DESCRIPTION RECEIVED FROM THE INITIAL REPORTER: THE DOCTOR WAS CHANGING THE PROSTHESIS WHEN A PIECE FELL OFF INTO THE PTS AIRWAY. THE DR. WAS ABLE TO SUCTION IT OUT. PT'S WIFE WAS CONTACTED AND BROUGHT THE RESERVE PROSTHESIS FROM HOME. THE BACKUP TEP WAS THEN CHANGED WITH NO PROBLEMS. THE DR. WAS UPSET AS SHE CLAIMS SHE HAS NEVER EXPERIENCED THIS BEFORE IN HER MANY YEARS OF DEALING WITH TEP CHANGES AND THE LARYNGECTOMY POPULATION. REF 7275 PROVOX XTRAFLANGE 22.5 WAS USED TOGETHER WITH THE PRODUCT. SEVERAL FOLLOW-UP QUESTIONS HAVE BEEN SENT AND ALSO REQUESTS FOR THE COMPLAINED PRODUCT BUT UNFORTUNATELY NO RESPONSE HAS BEEN RECEIVED BY THE COMPLAINANT. DESCRIPTION OF THE PRODUCT: PROVOX ACTIVALVE IS AN UNSTERILE INDWELLING VOICE PROSTHESIS INTENDED FOR ANTEROGRADE INSERTION IN A HEALED PUNCTURE FOR VOICE REHABILITATION AFTER TOTAL LARYNGECTOMY. THE DEVICE IS INTENDED FOR PATIENTS WHO ARE EXPERIENCING EARLY LEAKAGE WITH PREVIOUS VOICE PROSTHESES (DEVICE LIFE LESS THAN 4-8 WEEKS). THE DEVICE REDUCES THE NEED FOR FREQUENT REPLACEMENTS IN A MAJORITY OF USERS, BUT NOT IN ALL. THE VOICE PROSTHESIS IS SEATED IN A PUNCTURE IN THE WALL BETWEEN ESOPHAGUS AND TRACHEA.

  Patient problems: Insufficient Information

  MAUDE report 13827790 ↗
• MalfunctionMar 17, 2022Break; Break

  THIS IS THE EVENT DESCRIPTION RECEIVED FROM THE INITIAL REPORTER: THE DOCTOR WAS CHANGING THE PROSTHESIS WHEN A PIECE FELL OFF INTO THE PTS AIRWAY. THE DR. WAS ABLE TO SUCTION IT OUT. PT'S WIFE WAS CONTACTED AND BROUGHT THE RESERVE PROSTHESIS FROM HOME. THE BACKUP TEP WAS THEN CHANGED WITH NO PROBLEMS. THE DR. WAS UPSET AS SHE CLAIMS SHE HAS NEVER EXPERIENCED THIS BEFORE IN HER MANY YEARS OF DEALING WITH TEP CHANGES AND THE LARYNGECTOMY POPULATION. REF 7275 PROVOX XTRAFLANGE 22.5 WAS USED TOGETHER WITH THE PRODUCT. SEVERAL FOLLOW-UP QUESTIONS HAVE BEEN SENT AND ALSO REQUESTS FOR THE COMPLAIND PRODUCT BUT UNFORTUNATELY NO RESPONSE HAS BEEN RECIEVED BY THE MANUFACTURER. DESCRIPTION OF THE PRODUCT: PROVOX ACTIVALVE IS AN UNSTERILE INDWELLING VOICE PROSTHESIS INTENDED FOR ANTEROGRADE INSERTION IN A HEALED PUNCTURE FOR VOICE REHABILITATION AFTER TOTAL LARYNGECTOMY. THE DEVICE IS INTENDED FOR PATIENTS WHO ARE EXPERIENCING EARLY LEAKAGE WITH PREVIOUS VOICE PROSTHESES (DEVICE LIFE LESS THAN 4-8 WEEKS). THE DEVICE REDUCES THE NEED FOR FREQUENT REPLACEMENTS IN A MAJORITY OF USERS, BUT NOT IN ALL. THE VOICE PROSTHESIS IS SEATED IN A PUNCTURE IN THE WALL BETWEEN ESOPHAGUS AND TRACHEA.

  Patient problems: Foreign Body In Patient

  MAUDE report 13802853 ↗