Class 1 Recall for Acclarent Inspira AIR Balloon Dilation System

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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.

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