US FDA has issued a formal Medical Device recall for Acclarent’s Inspira Air™ Balloon Dilatation System (size 18 x 40mm). The recall notice can be found here.
At the end of January Acclarent issued its own recall notice which can be found here.
The Acclarent Inspira Air™ device is used in the endoscopic treatment of airway stenosis, a congenital or acquired condition which can be corrected using balloon dilatation.
According to the FDA recall notice, “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. The company 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 notice requires medical professionals to immediately cease using the device in question and provides contact details to arrange return and reimbursement.