Events

Recall of Device Recall Inspira AIR Balloon Dilation system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acclarent, 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
    64625
  • Event Risk Class
    Class 2
  • Event Number
    Z-1863-2013
  • Event Initiated Date
    2013-01-11
  • Event Date Posted
    2013-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116654
  • 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
    Bronchoscope accessory - Product Code KTI
  • Reason
    Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
  • Action
    Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013

Device

Device Recall Inspira AIR Balloon Dilation system
  • Model / Serial
    Product code: BC1040A; All lots manufactured after March 1, 2011
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
  • Product Description
    Inspira AIR Balloon Dilation system. || Size 10 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.

Manufacturer

Acclarent, Inc.
  • Manufacturer Address
    Acclarent, Inc., 1525-B O'Brien Dr, Menlo Park CA 94025-1463
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA