Provox Brush Long 8404Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07331791015588), received between Jun 7, 2024 and Jan 28, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 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.

• InjuryJan 28, 2025Material Fragmentation; Material Fragmentation

  THE INFORMATION WAS OBTAINED AT THE TIME OF PHONE CALL FOR RECEIVING A PURCHASE ORDER FROM THE USER BY CUSTOMER SERVICE PERSONNEL IN ATOS DIVISION ON 2025/8/1. THE USER STATED THAT WHEN CLEANING THE VOICE PROSTHESIS, THE TIP OF BRUSH HEAD FELL DOWN INTO THE AIRWAY ON (B)(6) 2024. THE USER WAS TAKEN TO THE FUJINOMIYA CITY GENERAL HOSPITAL TO SEE THE USER'S MAIN DOCTOR BY AMBULANCE. THE DOCTOR WAS NOT THERE, SO ANOTHER DOCTOR ON DUTY AT THE TIME GAVE THE USER MEDICAL ATTENTION. THE DOCTOR CHECKED THE BRUSH HEAD BY X-RAY AND IT WAS TAKEN OUT. THE DOCTOR CONFIRMED THAT THE BRUSH HEAD GOT BROKEN BY THE STAINLESS-STEEL WIRE PART. THE USER EXPERIENCED BREATHLESSNESS AND DESCRIBED THE EVENT AS PAINFUL, BUT BESIDES THAT THE USER DID NOT EXPERIENCE ANY PROBLEMS. THE USER WENT ON A REGULAR OUTPATIENT VISIT TO SEE THE MAIN DOCTOR ON (B)(6) 2025 AND THE DOCTOR CONFIRMED THAT THE USER DID NOT HAVE ANY HEALTH ISSUE. ADDITIONAL INFORMATION:THE BRUSH HEAD DID NOT FALL INTO THE AIRWAY. ON THE DAY OF THE EVENT, 2024/30/12, THE USER WAS CLEANING THE VOICE PROSTHESIS WITH PROVOX BRUSH, AND THE BRUSH GOT STUCK IN THE TRACHEOESOPHAGEAL WALL BY ACCIDENT. THE TIP OF THE BRUSH HEAD WAS SNAPPED BY THE WIRE P

  Patient problems: Aspiration/Inhalation

  MAUDE report 21250624 ↗
• MalfunctionJun 7, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE USER STATED IN AN E-MAIL TO CUSTOMER SERVICE THAT THE TIP OF THE PROVOX BRUSH BROKE WHILE BRUSHING THE VOICE PROSTHESIS AND THE TIP WAS LEFT INSIDE THE TRACHEA. IT HAD HAPPENED 2 TIMES IN THE PAST. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION SINCE THE BRUSH TIP COULD BE RETRIEVED BY THE PATIENT AT BOTH EVENTS. THE PATIENT SUFFERED NO INJURIES FROM THE EVENTS, BUT FELT A BIT NERVOUS WHEN IT OCCURRED. DESCRIPTION OF THE PRODUCT: THE PROVOX BRUSH IS A DEVICE HELPING TO CLEAN PROVOX VOICE PROSTHESES OR FENESTRATION HOLES IN LARYTUBE OR CAN BE USED FOR APPLICATION OF FLOUROSILICONE OIL OR ANTI-CANDIDA MEDICATION INTO PROVOX VOICE PROSTHESES. THE DISTAL END OF THE BRUSH CAN HELP TO PLACE PROVOX PLUG AND PROVOX VEGA PLUG INTO THE VOICE PROSTHESIS. THE BRUSH IS INTENDED FOR SINGLE PATIENT RE-USE AND IS INTENDED FOR BOTH HOME AND CLINICAL USE BY PATIENT OR CLINICIAN. MAXIMAL USE 30 DAYS. INTENDED USE: PROVOX BRUSH IS A SINGLE PATIENT USE DEVICE INTENDED FOR CLEANING PROVOX VOICE PROSTHESES, FOR INSERTION OF PROVOX PLUG AND PROVOX VEGA PLUG, FOR APPLYING LUBRICANT AND ANTI-CANDIDA AGENTS AND FOR CLEANING OF FENESTRATION HOLES ON PROVOX LARYTUBES. THE PRODUCT IS INTENDED FOR USE

  Patient problems: Airway Obstruction

  MAUDE report 19481760 ↗