Acclarent Recalls Inspira AIR Balloon Dilation System
FDA has announced Acclarent has initiated a recall of its Inspira AIR Balloon Dilation System, size 18x40mm, product code BC1840A, manufactured between March 2011 and June 2011, according to an FDA recall notice.
The system is an airway balloon catheter intended to dilate and restore airflow to a patient's airways.
Acclarent initiated the recall in late January after the company identified the potential for the balloon to not deflate or to deflate slowly, which could result in airway obstruction until the balloon is deflated or removed.
Acclarent recommends customers immediately discontinue use of the Inspira AIR Balloon Dilation System, size 18X40mm (Product Code BC1840A).
Customers with questions about the recall can contact Acclarent at (866) 781-1173.
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