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Provox LaryTube 9/36 7606Recalls & reported problems

Atos Medical AB · Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips. · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791002151), received between Apr 9, 2021 and Apr 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionApr 9, 2021Material Fragmentation; Material Fragmentation

    THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: PART OF THE LARYTUBE BROKE OFF AND CUSTOMER HAD TO GO TO THE EMERGENCY ROOM TO HAVE IT TAKEN OUT. ADDITIONAL QUESTIONS SENT AND ANSWERED BY USER (VIA REPORTER): Q HAVE OTHER PRODUCTS/MEDICINES BEEN USED TOGETHER WITH THE PRODUCT? A NO. Q WHAT HAPPENED JUST BEFORE THE TUBE BROKE? A WE RINSED IT WITH WATER. Q WHICH PART OF THE TUBE WAS BROKEN OFF? A THE LITTLE THINGS THAT HOLD THE BAND. Q WHY DID THE USER NEED TO GO TO THE EMERGENCY? A MY HUSBAND WAS HAVING TROUBLE BREATHING. Q WHERE WAS THE BROKEN PART? A THE ENT PULLED IT OUT SO IN THE AIRWAY. Q IN WHICH WAY WAS THE USER HELPED IN THE EMERGENCY? A ENT REMOVED A PART OF THE TUBE. Q WHICH INSTRUMENTS/EQUIPMENT WAS USED? A I DO NOT KNOW, BECAUSE I WAS NOT IN THE ROOM. Q HOW IS THE USER FEELING TODAY? A HE IS FEELING BETTER, BUT RECOVERING FROM HIS CHEMO AND RADIATION. Q ARE YOU SURE THAT THE TUBE IS NOT AVAILABLE FOR RETURN? A PRODUCT RETURN WOULD HELP US IN THE INVESTIGATION. A YES. Q ARE ANY PICTURES OF THE TUBE AVAILABLE? A I SENT ALL THE PICTURES I HAD TO (B)(6). ATTACHED IS THE ONLY PICTURE THAT I WAS SENT ALTHOUGH YOU CANNOT SEE MUCH. Q IS IT THE RED-ISH PART S

    Patient problems: Foreign Body In Patient

    MAUDE report 11640572 ↗

Other Tube, Laryngectomy devices

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Sources and updates

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