Provox ActiValve Strong 6 mm 7161Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07331791000584), received between Sep 26, 2024 and Feb 18, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS AN END USER OF A PROVOX ACTIVALVE STRONG VOICE PROSTHESIS (22.5FR/6MM) DURING USE THE DEVICE WAS PLACED IN (B)(6) 2025. APPROXIMATELY FOUR MONTHS LATER, THE PATIENT REPORTED TO THE SPEECH LANGUAGE PATHOLOGIST (SLP) THAT THE SMALL BLUE CENTER PIECE DETACHED WHILE DRINKING AND WAS SWALLOWED BY THE PATIENT. THE PATIENT REPORTED FEELING THE PIECE, SPITTING IT BACK UP, AND THEN EXPERIENCING CHOKING DURING THE NEXT SIP OF LIQUID. THE PATIENT REPORTED THAT WITHOUT THE SMALL BLUE CENTER PIECE, HE WAS CHOKING AND UNABLE TO VOICE/COMMUNICATE. THE SPEECH LANGUAGE PATHOLOGIST (SLP) EVALUATED THE PATIENT THE FOLLOWING MORNING IN CLINIC, REMOVED THE DEVICE, AND PLACED A NEW, DIFFERENT DEVICE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 24380279 ↗
• InjuryFeb 17, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS AN END USER OF A PROVOX ACTIVALVE STRONG VOICE PROSTHESIS (22.5FR/6MM) DURING USE THE DEVICE WAS PLACED IN (B)(6) 2025. APPROXIMATELY FOUR MONTHS LATER, THE PATIENT REPORTED TO THE SPEECH LANGUAGE PATHOLOGIST (SLP) THAT THE SMALL BLUE CENTER PIECE DETACHED WHILE DRINKING AND WAS SWALLOWED BY THE PATIENT. THE PATIENT REPORTED FEELING THE PIECE, SPITTING IT BACK UP, AND THEN EXPERIENCING CHOKING DURING THE NEXT SIP OF LIQUID. THE PATIENT REPORTED THAT WITHOUT THE SMALL BLUE CENTER PIECE, HE WAS CHOKING AND UNABLE TO VOICE/COMMUNICATE. THE SPEECH LANGUAGE PATHOLOGIST (SLP) EVALUATED THE PATIENT THE FOLLOWING MORNING IN CLINIC, REMOVED THE DEVICE, AND PLACED A NEW, DIFFERENT DEVICE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Aspiration/Inhalation; Localized Skin Lesion

  MAUDE report 24365489 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS COMMITTED TWICE TO THE EMERGENCY DEPARTMENT ON AN EMERGENCY BASIS DUE TO SUSPECTED ASPIRATION OF FOREIGN BODY (PROVOX ACTIVALVE STRONG) INTO THE RESPIRATORY TRACT. FIRST TIME 2024-08-17 AN ENDOSCOPY THROUGH THE PROTHESIS AND A CHEST X-RAY WERE PERFORMED, NO FOREIGN BODY WAS VISIBLE IN RESPIRATORY TRACT. SECOND TIME 2024-08-19 PATIENT COMPLAINED OF SHORTNESS OF BREATH AFTER CLEANING THE DENTURE, CLAIMING THAT HE PROBABLY ASPIRATED WHOLE PROVOX ACTIVALVE STRONG. DUE TO STRONG SUSPICIOUS OF FOREIGN BODY ASPIRATION INTO THE RESPIRATORY TRACT CHEST CT WAS PERFORMED AND PROVOX ACTIVALVE WAS REMOVED SAFETY FROM LEFT BRONCHUS MAIN. AFTER HOSPITALIZATION (2 DAYS) PATIENT WAS ADMITTED HOME.

  Patient problems: Aspiration/Inhalation

  MAUDE report 20307994 ↗