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Provox XtraMoist HME (30 pcs) 7290Recalls & reported problems

Atos Medical AB · The Provox XtraHME Cassette is a single use, specialized device intended for patients breathing through a tracheostoma. It is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. It partially restores lost breathing resistance. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing. · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791005893), received between Apr 27, 2018 and Apr 27, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE REPORTING DERMATOLOGIST: PATIENT HAD BEEN USING A PROVOX HME FILTER (WITH THE PROVOX ADHESIVE BASE) FOR HER TRACHEOSTOMY FOR OVER 10 YEARS WITHOUT ANY PROBLEMS. AROUND EASTER 2016 SHE WENT TO GET A REPEAT PRESCRIPTION AND THE PHARMACIST ADVISED HER THAT THE CODE NUMBER HAS CHANGED, THE ONLY CHANGE SHE HAD NOTED WAS THAT THE COLOR HAD CHANGED FROM WHITE TO BEIGE. SOON AFTER THIS SHE STARTED TO DEVELOP AN ECZEMATOUS REACTION AROUND THE STOMA SITE WITH CHRONIC INFLAMMATION AND RECURRENT INFECTIONS AND DEVELOPED A CONTRACTURE OF THE STOMA SITE WHICH REQUIRED A SURGICAL INTERVENTION TO CORRECT.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 7468160 ↗

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Sources and updates

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