Inspira AIR Balloon Dilation System poses choking hazard
Acclarent Incorporated has issued a recall for its Inspira AIR Balloon Dilation System catheter due to a risk of airway obstruction. The Inspira AIR Balloon Dilation System was manufactured from March 2011 to June 2011, and measures 18 millimeters by 40 millimeters. The affected units have the product code BC1840A.
The balloon catheter, designed to dilate and restore proper airflow in a patient’s airways, has potential problems with deflation, causing it to obstruct airflow. Acclarent has registered four complaints regarding these problems, including one instance in which the patient was injured. In every case, the surgeon installing the Inspira AIR Balloon Dilation System attempted to adjust the catheter as it shifted away, stretching the balloon and narrowing its catheter shaft, making deflation problematic if not impossible. If the airway obstruction is not remedied, the flow of oxygen to the bloodstream may be interrupted causing a risk of serious physical
Acclarent recommends patients using its Inspira AIR Balloon Dilation discontinue doing so immediately, and return it to the manufacturer for a full refund. The product poses a potentially life threatening health hazard.
As a Bakersfield personal injury lawyer I hope this defective product is successfully recalled before it causes harm to anyone. If you or someone you care about has been harmed by a malfunctioning medical device, please consider discussing your case with a well qualified San Francisco personal injury attorney.