Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.

Recall Class: Class I

Date Recall Initiated: January 30, 2012.

Product: Acclarent Inspira AIR Balloon Dilation System, size 18x40mm, product code BC1840A, manufactured between March 2011 and June 2011.

Use: The Inspira AIR Balloon Dilation System is an airway balloon catheter intended to dilate and restore airflow to a patient’s airways.

Recalling Firm:
Acclarent, Inc.
1525b Obrien Drive
Menlo Park, California 94025-1463

Reason for Recall: Acclarent 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. Prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient. This product may cause serious adverse health consequences, including death.

The company has received four reports of incidents, one resulting in patient injury, in which the device has apparently malfunctioned. In each of these cases, difficulty deflating the balloon occurred after the surgeon pulled against resistance in response to the balloon moving distally during dilation. The force applied to the catheter stretched and narrowed the catheter shaft, causing the balloon to be difficult or impossible to deflate.

Public Contact: Customers with questions about this recall can contact Acclarent at 1-866-781-1173.

FDA District: San Francisco

FDA Comments: Acclarent recommends customers immediately discontinue use of the Inspira AIR Balloon Dilation System, size 18X40mm (Product Code BC1840A).

On January 31, 2012, Acclarent mailed an Urgent Voluntary Product Recall to affected customers. The letter provides instructions for returning affected products to Stericycle. An attachment to the letter provides information and photographs to help customers identify recalled product in their inventory. Acclarent is offering a refund to customers for all affected product returned. For more information, customers can contact Acclarent directly at 1-866-781-1173 or contact their Acclarent Sales Representative.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, by telephone, or by FAX.