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Acclarent Inspira Air Balloon Dilation Recall

The FDA has announced the recall of the Inspira AIR balloon dilation system, after determining that there is a reasonable probability that problems with the device will cause serious injuries or death.

On January 31, 2012, Acclarent, makers of the Inspira AIR Balloon Dilation System, sent urgent information to medical providers regarding the recall. It has been determined that the Inspira AIR Balloon Dilation System, an airway balloon catheter intended to dilate and restore airflow to a patient’s airways, could fail to deflate or deflate slowly, blocking a patient’s airway until the balloon is deflated or removed, possibly leading to temporary, permanent or fatal injuries.

There have been at least four incidents linked to the air balloon dilation problems, one of which resulted in injury to a patient. In each case, the device malfunctioned during surgery, when the balloon moved during dilation and the surgeon tried to pull it into place. The catheter shaft narrowed when the surgeon pulled, preventing the balloon from deflating.

Thankfully, this was discovered prior to any deaths, but why did four incidents have to occur before this was recalled? Why not two? Why not one? I have a feeling that the person who was the “one” injury would like to know the answer to that.