Events

Safety Alert for Inspira AIR Balloon Dilation System, size 18X40mm

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Acclarent.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-03-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120314b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: acclarent inspira air balloon dilation system, size 18x40mm the food and drug administration (fda), united states, has issued a class i recall concerning inspira air balloon dilation system, size 18x40mm (product code: bc1840a) manufactured by acclarent, inc.. fda reported that there is potential for the balloon to not deflate or to deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient. this product may cause serious adverse health consequences, including death. according to the report, the manufacturer has received four reports of incidents, one resulting in patient injury, in which the device has apparently malfunctioned. in each of these cases, difficulty deflating the balloon occurred after the surgeon pulled against resistance in response to the balloon moving distally during dilation. the force applied to the catheter stretched and narrowed the catheter shaft, causing the balloon to be difficult or impossible to deflate. the manufacturer recommends customers immediately discontinue use of the affected products. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm295488.Htm and http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm295875.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

Inspira AIR Balloon Dilation System, size 18X40mm
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm
  • Manufacturer
    Acclarent

Manufacturer

Acclarent