Consumer Lawyers

Acclarent Recalls Inspira AIR Balloon Dilation System

In Uncategorized on March 15, 2012 at 1:02 am

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

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