Urgent Safety Information for the Inspira AIR™ Balloon Dilation System, Acclarent Inc.
2013.09.02
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04894/13
The Acclarent Inc. informs per FSN about a new warning in the IFU of the Inspira AIR™ Balloon Dilation System. Difficulty deflating may occur after the user had pulled against resistance in response to the balloon moving distally during dilation.