The system is an airway balloon catheter intended to dilate and restore airflow to a patient’s airways.
Acclarent initiated the recall in late January after the company 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.
Acclarent recommends customers immediately discontinue use of the Inspira AIR Balloon Dilation System, size 18X40mm (Product Code BC1840A).
Customers with questions about the recall can contact Acclarent at (866) 781-1173.
Related Articles on Product Recalls:
FDA Seeks Stricter Regulations on Hip Implants, Vaginal Mesh
American Regent Recalls One Lot of Phenylephrine HCI Injection
FDA Announces 2012 Medical Device Strategic Priorities
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
