Provox LaryTube 9/55 7607Recalls & 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 07331791002175), received between Jun 29, 2017 and Jun 29, 2017 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Improper or Incorrect Procedure or Method1
Material Rupture1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

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

MalfunctionJun 29, 2017Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method
THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE ATOS MEDICAL LOCAL REPRESENTATIVE: THE PRODUCT WAS IN 6 WEEKS FROM PURCHASE, PT REMOVED ONE PM TO CLEAN AND NOTICED PIECE MISSING AT THAT TIME SHE COUGHED AND FELT SOMETHING FLY OUT (ASSUMPTION THE MISSING PIECE). ACTUAL DATE OF EVENT NOT RECALLED, ITEM BOUGHT AT THE (B)(6) CLINIC (B)(6) 2017. PT USED H2O & HYDROGEN PEROXIDE FOR CLEANING AS PER TEACHING. PT USES WATER BASED LUBRICANT TO EASE INSERTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6676473 ↗

Device details

UDI-DI	`07331791002175`
Brand	Provox LaryTube 9/55
Model	7607
Company	Atos Medical AB
Product code	KAC · Tube, Laryngectomy
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Nov 29, 2024

Device type (GMDN): Tracheostomy tube, non-reinforced, non-customized, reusable

A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.

Other Tube, Laryngectomy devices

Provox LaryTube 9/36 7606
Atos Medical AB · Tube, Laryngectomy
1 report

All Tube, Laryngectomy devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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