Acclarent Issues Recall for Balloon Catheter

Acclarent has issued a Class I recall for its airway balloon catheterbecause the device may malfunction and result in patient injury.

The recall is in effect for the Inspira AIR Balloon Dilation System after four incidents were reported involving an apparent malfunction of the device, which led to one patient injury, according to a safety alert by the Food and Drug Administration. In each of the incidents, the surgeon had difficulty deflating the balloon and the force applied to the catheter caused difficultly deflating the balloon.

The Inspira System is used to dilate and restore airflow to a patient’s airways during surgical procedures

The FDA describes a Class I recall as “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation. A product liability lawyer may be able to help you.