FDA Recalls Balloon Catheter

Acclarent Inspira AIR Balloon Dilation System recalled by FDA

(RxWiki News) Acclarent, Inc initiated a recall of their balloon catheter device designed to dilate and restore airflow to a patient's airways.

The recall of the Acclarent Inspira AIR Balloon Dilation System, size 18x40mm, product code BC1840A, was considered a Class I recall, suggesting the device could result in serious injury or death.

"Surgeons should discontinue use of the balloon catheter immediately."

The devices in question were manufactured between March 2011 and June 2011. The urgent voluntary recall was initiated by the California-based company on Jan. 30, though the FDA announced the recall on March 13.

The devices were recalled when Acclarent found they have the potential for the balloon to not deflate or to deflate slowly. This could result in obstruction of the airway until the device is removed or deflated.

Patients that received prolonged airway obstruction could experience inadequate blood oxygenation, prompting temporary or permanent injury including death.

Acclarent has received four reports of serious incidents in which patients were injured when the device malfunctioned. In all four cases surgeons had difficulty deflating the balloon after pulling against resistance when the balloon moved while dilating the airway.

Because of the force, which stretched and narrowed the catheter shaft, doctors found it difficult or impossible to deflate the device.

Acclarent recommends immediately discontinuing use of the product. Consumers with questions about this recall are asked to contact Acclarent at 1-866-781-1173. Customers will receive refunds when returning recalled products.

Review Date: 
March 15, 2012