Class 1 recall: Acclarent airway catheter
Acclarent is recalling its Inspira AIR, a balloon catheter system used to dilate blocked airways and restore breathing in patients with airway stenosis.
The company told the FDA that four reports of incidents have come in. In each, the device evidently malfunctioned and, in one, a patient was injured. In each case the surgeon struggled to deflate the balloon after it shifted unexpectedly during dilation. Inflated for a prolonged period, the balloon can block airflow. In a worst-case scenario, the result is asphyxiation.
According to an FDA notice on the Class 1 recall, the affected units were manufactured between March 2011 and June 2011.
Airway stenosis, a constriction that blocks air from reaching the lungs, is most commonly seen in patients who depend on a tracheotomy tube to breathe.
Menlo Park, Calif.-based Acclarent mailed affected customers an urgent voluntary recall of the device Jan. 31. The company is providing refunds for all affected products returned.
The company told the FDA that four reports of incidents have come in. In each, the device evidently malfunctioned and, in one, a patient was injured. In each case the surgeon struggled to deflate the balloon after it shifted unexpectedly during dilation. Inflated for a prolonged period, the balloon can block airflow. In a worst-case scenario, the result is asphyxiation.
According to an FDA notice on the Class 1 recall, the affected units were manufactured between March 2011 and June 2011.
Airway stenosis, a constriction that blocks air from reaching the lungs, is most commonly seen in patients who depend on a tracheotomy tube to breathe.
Menlo Park, Calif.-based Acclarent mailed affected customers an urgent voluntary recall of the device Jan. 31. The company is providing refunds for all affected products returned.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.