Federal health regulators are warning that defects with the Inspira AIR balloon dilation system could lead to patient deaths.
The FDA classified an Inspira dilation system recall as a Class I medical device recall on March 13, indicating that the agency believes there is a reasonable probability that problems with the device will cause serious injuries or death.
The Inspira, manufactured by Acclarent, Inc., is an airway balloon catheter used to dilate and restore airflow for patients having problems breathing.
It has been discovered that the dilation balloon used in the Inspira could fail to deflate or deflate slowly, blocking a patient’s airway until the balloon is deflated or removed. This could lead to temporary, permanent or fatal injuries.
There have been at least four incidents linked to the air balloon dilation problems, one of which resulted in patient injury. In all four cases, the device malfunctioned during surgery, when the balloon moved during dilation and the surgeon tried to pull it into place. The catheter shaft narrowed when the surgeon pulled, preventing the balloon from deflating.
The recall affects the Acclarent Inspira AIR Balloon Dilation System, size 19-x40mm. It was manufactured between March 2011 and June 2011 and has a product code of BC1840A.
The recall was first announced on January 30, in a letter mailed by Acclarent to its customers. The company recommends that customers immediately discontinue use of the Inspira and send them to Stericycle to be recycled. The company has promised to pay a full refund. Customers with questions can call Acclarent at (866) 781-1173.