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.


Related Articles on Product Recalls:

FDA Seeks Stricter Regulations on Hip Implants, Vaginal Mesh

American Regent Recalls One Lot of Phenylephrine HCI Injection

FDA Announces 2012 Medical Device Strategic Priorities

© Copyright ASC COMMUNICATIONS 2017. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.


Top 40 Articles from the Past 6 Months