The FDA has recalled Acclarent Inspira AIR Balloon Dilation System, size 18x40mm, product code BC1840A, manufactured between March 2011 and June 2011. This device is an airway balloon catheter intended to dilate and restore airflow to a patient’s airways.
Acclarent identified the 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.
Four reports of incidents have been received, 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.
Acclarent recommends customers immediately discontinue use of the Inspira AIR Balloon Dilation System, size 18X40mm (Product Code BC1840A).
Health care professionals and consumers may report adverse reactions or quality problems they experienced using the product to the MedWatch FDA Safety Information and Adverse Event Reporting Program.
See the FDA Recall