Provox Brush XL 7225Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07331791001451), received between Sep 25, 2019 and Aug 4, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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.

• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: BRUSH HEAD BROKE OFF AND LODGED IN TRACHEAL WALL. CLIENT INDICATES X-RAY CONFIRMED PRESENCE OF BRUSH HEAD IN TRACHEA. CLIENT IS AT EMERGENCY DEPARTMENT FOR EXTRACTION. THIRD RECURRENCE ON THIS USER. PREVIOUS REPORT INDICATES BRUSH HEAD WAS BET AT THE WIRE INSTEAD OF AT THE STEM. THE CLIENT UPDATED US THAT THEY RETURNED HOME FROM THE EMERGENCY DEPARTMENT AT 5PM . DESCRIPTION OF THE PRODUCT: PROVOX BRUSH IS A DEVICE INTENDED FOR CLEANING OF PROVOX VOICE PROSTHESIS IN-SITU. CLEANING IS RECOMMENDED TWICE A DAY AND AFTER EACH MEAL.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10361176 ↗
• MalfunctionMar 17, 2020Material Rupture; Material Rupture

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: I WOKE UP COUGHING AND WENT TO WASHROOM FOR HYGIENE. DURING REGULAR PROCEDURE THE BRUSH BROKE AT THE COLLAR INSIDE MY STOMA. I COULD NOT SEE THE BRUSH HEAD AND WAS UNABLE TO COUGH IT UP. I DECIDED TO TRY TO STAY CALM AND HOPE IT WOULD EVENTUALLY COUGH UP OVER THE NIGHT. AS THAT DID NOT HAPPEN I PROCEEDED TO (B)(6) EMERGENCY AFTER MY WIFE, (B)(6), CONFIRMED THEY HAD AN E.N.T. AVAILABLE, AND THEY INSTRUCTED ME TO COME IN ASAP. I'LL SHORTEN THE NEXT 8 HRS: XRAY DID NOT SHOW OBJECT SO BRONCOSCOPY PERFORMED SEVERAL TIMES TO THE MAXIMUM EXTENT AN E.N.T. DOCTOR IS ALLOWED (INTO THE BRONCHIAL TUBES BUT NOT THE LUNGS. THEN A RESPIROLOGIST WAS BROUGHT IN. BECAUSE THIS DOCTOR WAS INSISTENT THAT THE XRAY SHOULD HAVE SHOWN AN OBJECT WITH METAL IN IT HE REPEATEDLY ASKED IF I WAS CERTAIN THE BRUSH HEAD WENT DOWN MY TRACHEA. I THEN TEXTED (B)(6) TO RECHECK THE BATHROOM AND HALLELUJAH IT WAS ON THE FLOOR IN A GROUT TRACK! I WAS STRUCK WITH 2 FEELINGS 1/ EXTREME GRATITUDE THAT LUNG INTERVENTION WAS NOT REQUIRED, AND 2/ EXTREME EMBARRASSMENT AS I WAS CERTAIN THAT IT WENT DOWN MY TRACHEA. THE ENTIRE GROUP WAS ELATED AND PLEASED FOR M

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9841767 ↗
• MalfunctionSep 25, 2019Material Rupture; Material Rupture

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: SWIVEL DETACHED AT THE JUNCTURE TO PLASTIC HANDLE. THE BRUSH END DROPPED INTO TRACHEA. FORTUNATELY I WAS ABLE TO COUGH IT UP AND EXTRACT IT, AFTER SEVERAL ATTEMPTS. I ASSURE YOU NOTHING ABNORMAL IE: PRESSURE APPLIED. BRUSH USED IS ONE OF TWO USED DAILY AND CHANGED EVERY MONTH. I WAS FRIGHTENED, NOT A CONDITION I AM USED TO. DESCRIPTION OF THE PRODUCT: PROVOX BRUSH IS A DEVICE INTENDED FOR CLEANING OF PROVOX VOICE PROSTHESIS IN-SITU. CLEANING IS RECOMMENDED TWICE A DAY AND AFTER EACH MEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9117902 ↗