Events

Recall of Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alveolus, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29886
  • Event Risk Class
    Class 2
  • Event Number
    Z-1487-04
  • Event Initiated Date
    2004-04-22
  • Event Date Posted
    2004-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34727
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, Larynx (Stents And Keels) - Product Code FWN
  • Reason
    The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.
  • Action
    Consignees were notified by telephone on 4/22/2004.

Device

Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 ...
  • Model / Serial
    Size 12x40, Part #90129-20, Lot #AC0406; Size 14x40, Part #90129-21, Lot #AC0409; Size 16x40, Part #90129-22, Lot #AA0411; Size 16x60, Part #90129-23, Lot #A0413; Size 12x20, Part #90129-24, Lot #AA0404; Size 14x40, Part #90129-25, Lot 3AA0409; Size 14x40, Part #90129-26, Lot #AC0409; Size 16x60, Part #90129-27, Lot #AA0413
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, SC, TX
  • Product Description
    Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202
  • Manufacturer
    Alveolus, Inc.

Manufacturer

Alveolus, Inc.
  • Manufacturer Address
    Alveolus, Inc., 401 N Tryon St Fl 10th, Charlotte NC 28202-2108
  • Source
    USFDA