Acclarent Inspira AIR Balloon Dilation System - Class 1 Recall
MedSun: Newsletter #71, April 2012

FDA MedWatch Safety Alert

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.

Additional Information:

FDA MedWatch Safety Alert. Acclarent Inspira AIR Balloon Dilation System - Class 1 Recall. March 13, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm295875.htm


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