BigClassActions.com

Class 1 Recall for Acclarent Inspira AIR Balloon Dilation System

- by

Washington, DC: A class 1 recall has been issued for the Acclarent Inspira AIR Balloon Dilation System because it has the potential not to deflate, or to deflate slowly.

The Inspira AIR Balloon Dilation System is an airway balloon catheter intended to dilate and restore airflow to a patient' airways. Acclarent 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.

Legal Help

If you or a loved one has suffered injury or damages in this case, please fill in our form on the right and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.

Add Your Comment on This Issue

Fields marked * are mandatory. Please read our comment guidelines before posting.

*Name:

Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.

*Your Comment:
Request Legal Help