The Food and Drug Administration (FDA), United States, has issued a Class I recall concerning Inspira AIR Balloon Dilation System, size 18X40mm (Product Code: BC1840A) manufactured by Acclarent, Inc..
FDA reported that there is 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.
According to the report, the manufacturer 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 manufacturer recommends customers immediately discontinue use of the affected products.
For details, please visit the following FDA website:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm295488.htm and
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm295875.htm
If you are in possession of the product, please contact your supplier for necessary actions.