Provox2 Voice Prosthesis 8mm 7218Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07331791010026), received between Feb 12, 2025 and Feb 12, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THIS REPORT REFLECTS ASPIRATION OF PROVOX2 WITH MODIFIED FLANGES EVENT 5 OUT OF 5 WHERE TRACHEAL RETRIEVAL WAS NECESSARY. ADVERSE EVENTS WERE FOUND DURING LITERATURE REVIEW FOR THE PERIODIC UPDATE OF THE CLINICAL EVALUATION REPORT FOR VOICE PROSTHESES. THE FOLLOWING TEXT WAS FOUND IN ARTICLE BY EBERSOLE BM, ZAFEREO M, HUTCHESON KA. A CUSTOM DEVICE FOR MANAGING RECURRENT TRACHEOESOPHAGEAL VOICE PROSTHESIS DISLODGEMENT AND ASPIRATION DUE TO TREATMENT REFRACTORY, SEVERELY ENLARGED PUNCTURE: A VIDEO CASE REPORT. HEAD & NECK. 2024;1-7. DOI:10.1002/ HED.27766). "HE WAS EVENTUALLY REFRACTORY TO THESE TREATMENTS AND USING A PROVOX 2 WITH CUSTOMIZED ANTERIOR AND POSTERIOR FLANGES (UP TO 30 MM DIAMETER SILICONE COLLARS), ACHIEVING VARIABLE ASPIRATION CONTROL. SILICONE OF VARYING THICKNESSES (0.015¿0.030 MM) AND DIAMETERS (23¿30 MM) WERE TRIALED IN THE FABRICATION OF HIS CUSTOM FLANGES TO IMPROVE THEIR STABILITY/SUPPORT, BUT WITH LITTLE EFFECT. IN THE 2 YEARS PRECEDING THE USE OF THE NEW INSET-VP DEVICE, 24 VP DISLODGEMENTS WERE REPORTED WITH 5 REQUIRING ED ADMISSION FOR TRACHEAL RETRIEVAL. ROOT CAUSES OF VP DISLODGEMENT WERE JUDGED TO BE DUE TO DISRUPTION OF FLANGE SEATING DURING SELF-DILATI

  Patient problems: Aspiration/Inhalation

  MAUDE report 21362900 ↗
• InjuryFeb 12, 2025Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THIS REPORT REFLECTS ASPIRATION OF PROVOX2 WITH MODIFIED FLANGES EVENT 4 OUT OF 5 WHERE TRACHEAL RETRIEVAL WAS NECESSARY. ADVERSE EVENTS WERE FOUND DURING LITERATURE REVIEW FOR THE PERIODIC UPDATE OF THE CLINICAL EVALUATION REPORT FOR VOICE PROSTHESES. THE FOLLOWING TEXT WAS FOUND IN ARTICLE BY EBERSOLE BM, ZAFEREO M, HUTCHESON KA. A CUSTOM DEVICE FOR MANAGING RECURRENT TRACHEOESOPHAGEAL VOICE PROSTHESIS DISLODGEMENT AND ASPIRATION DUE TO TREATMENT REFRACTORY, SEVERELY ENLARGED PUNCTURE: A VIDEO CASE REPORT. HEAD & NECK. 2024;1-7. DOI:10.1002/ HED.27766). "HE WAS EVENTUALLY REFRACTORY TO THESE TREATMENTS AND USING A PROVOX 2 WITH CUSTOMIZED ANTERIOR AND POSTERIOR FLANGES (UP TO 30 MM DIAMETER SILICONE COLLARS), ACHIEVING VARIABLE ASPIRATION CONTROL. SILICONE OF VARYING THICKNESSES (0.015¿0.030 MM) AND DIAMETERS (23¿30 MM) WERE TRIALED IN THE FABRICATION OF HIS CUSTOM FLANGES TO IMPROVE THEIR STABILITY/SUPPORT, BUT WITH LITTLE EFFECT. IN THE 2 YEARS PRECEDING THE USE OF THE NEW INSET-VP DEVICE, 24 VP DISLODGEMENTS WERE REPORTED WITH 5 REQUIRING ED ADMISSION FOR TRACHEAL RETRIEVAL. ROOT CAUSES OF VP DISLODGEMENT WERE JUDGED TO BE DUE TO DISRUPTION OF FLANGE SEATING DURING SELF-DILATI

  Patient problems: Aspiration/Inhalation

  MAUDE report 21362844 ↗
• InjuryFeb 12, 2025Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THIS REPORT REFLECTS ASPIRATION OF PROVOX2 WITH MODIFIED FLANGES EVENT 3 OUT OF 5 WHERE TRACHEAL RETRIEVAL WAS NECESSARY. ADVERSE EVENTS WERE FOUND DURING LITERATURE REVIEW FOR THE PERIODIC UPDATE OF THE CLINICAL EVALUATION REPORT FOR VOICE PROSTHESES. THE FOLLOWING TEXT WAS FOUND IN ARTICLE BY EBERSOLE BM, ZAFEREO M, HUTCHESON KA. A CUSTOM DEVICE FOR MANAGING RECURRENT TRACHEOESOPHAGEAL VOICE PROSTHESIS DISLODGEMENT AND ASPIRATION DUE TO TREATMENT REFRACTORY, SEVERELY ENLARGED PUNCTURE: A VIDEO CASE REPORT. HEAD & NECK. 2024;1-7. DOI:10.1002/ HED.27766). "HE WAS EVENTUALLY REFRACTORY TO THESE TREATMENTS AND USING A PROVOX 2 WITH CUSTOMIZED ANTERIOR AND POSTERIOR FLANGES (UP TO 30 MM DIAMETER SILICONE COLLARS), ACHIEVING VARIABLE ASPIRATION CONTROL. SILICONE OF VARYING THICKNESSES (0.015¿0.030 MM) AND DIAMETERS (23¿30 MM) WERE TRIALED IN THE FABRICATION OF HIS CUSTOM FLANGES TO IMPROVE THEIR STABILITY/SUPPORT, BUT WITH LITTLE EFFECT. IN THE 2 YEARS PRECEDING THE USE OF THE NEW INSET-VP DEVICE, 24 VP DISLODGEMENTS WERE REPORTED WITH 5 REQUIRING ED ADMISSION FOR TRACHEAL RETRIEVAL. ROOT CAUSES OF VP DISLODGEMENT WERE JUDGED TO BE DUE TO DISRUPTION OF FLANGE SEATING DURING SELF-DILATI

  Patient problems: Aspiration/Inhalation

  MAUDE report 21362823 ↗
• InjuryFeb 12, 2025Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THIS REPORT REFLECTS ASPIRATION OF PROVOX2 WITH MODIFIED FLANGES EVENT 2 OUT OF 5 WHERE TRACHEAL RETRIEVAL WAS NECESSARY. ADVERSE EVENTS WERE FOUND DURING LITERATURE REVIEW FOR THE PERIODIC UPDATE OF THE CLINICAL EVALUATION REPORT FOR VOICE PROSTHESES. THE FOLLOWING TEXT WAS FOUND IN ARTICLE BY EBERSOLE BM, ZAFEREO M, HUTCHESON KA. A CUSTOM DEVICE FOR MANAGING RECURRENT TRACHEOESOPHAGEAL VOICE PROSTHESIS DISLODGEMENT AND ASPIRATION DUE TO TREATMENT REFRACTORY, SEVERELY ENLARGED PUNCTURE: A VIDEO CASE REPORT. HEAD & NECK. 2024;1-7. DOI:10.1002/ HED.27766). "HE WAS EVENTUALLY REFRACTORY TO THESE TREATMENTS AND USING A PROVOX 2 WITH CUSTOMIZED ANTERIOR AND POSTERIOR FLANGES (UP TO 30 MM DIAMETER SILICONE COLLARS), ACHIEVING VARIABLE ASPIRATION CONTROL. SILICONE OF VARYING THICKNESSES (0.015¿0.030 MM) AND DIAMETERS (23¿30 MM) WERE TRIALED IN THE FABRICATION OF HIS CUSTOM FLANGES TO IMPROVE THEIR STABILITY/SUPPORT, BUT WITH LITTLE EFFECT. IN THE 2 YEARS PRECEDING THE USE OF THE NEW INSET-VP DEVICE, 24 VP DISLODGEMENTS WERE REPORTED WITH 5 REQUIRING ED ADMISSION FOR TRACHEAL RETRIEVAL. ROOT CAUSES OF VP DISLODGEMENT WERE JUDGED TO BE DUE TO DISRUPTION OF FLANGE SEATING DURING SELF-DILATI

  Patient problems: Aspiration/Inhalation

  MAUDE report 21362807 ↗
• InjuryFeb 12, 2025Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THIS REPORT REFLECTS ASPIRATION OF PROVOX2 WITH MODIFIED FLANGES EVENT 1 OUT OF 5 WHERE TRACHEAL RETRIEVAL WAS NECESSARY. ADVERSE EVENTS WERE FOUND DURING LITERATURE REVIEW FOR THE PERIODIC UPDATE OF THE CLINICAL EVALUATION REPORT FOR VOICE PROSTHESES. THE FOLLOWING TEXT WAS FOUND IN ARTICLE BY EBERSOLE BM, ZAFEREO M, HUTCHESON KA. A CUSTOM DEVICE FOR MANAGING RECURRENT TRACHEOESOPHAGEAL VOICE PROSTHESIS DISLODGEMENT AND ASPIRATION DUE TO TREATMENT REFRACTORY, SEVERELY ENLARGED PUNCTURE: A VIDEO CASE REPORT. HEAD & NECK. 2024;1-7. DOI:10.1002/ HED.27766). "HE WAS EVENTUALLY REFRACTORY TO THESE TREATMENTS AND USING A PROVOX 2 WITH CUSTOMIZED ANTERIOR AND POSTERIOR FLANGES (UP TO 30 MM DIAMETER SILICONE COLLARS), ACHIEVING VARIABLE ASPIRATION CONTROL. SILICONE OF VARYING THICKNESSES (0.015¿0.030 MM) AND DIAMETERS (23¿30 MM) WERE TRIALED IN THE FABRICATION OF HIS CUSTOM FLANGES TO IMPROVE THEIR STABILITY/SUPPORT, BUT WITH LITTLE EFFECT. IN THE 2 YEARS PRECEDING THE USE OF THE NEW INSET-VP DEVICE, 24 VP DISLODGEMENTS WERE REPORTED WITH 5 REQUIRING ED ADMISSION FOR TRACHEAL RETRIEVAL. ROOT CAUSES OF VP DISLODGEMENT WERE JUDGED TO BE DUE TO DISRUPTION OF FLANGE SEATING DURING SELF-DILATI

  Patient problems: Aspiration/Inhalation

  MAUDE report 21362784 ↗