The FDA has handed down a Class I label, the agency’s most serious, to a Medtronic recall of medical tubing used to drain a patient’s cerebrospinal fluid.
The recall spans more than 45,000 equipment sets distributed in the U.S. from May 2021 through January of this year, when the medtech giant alerted healthcare providers to a potential issue where its Duet collection catheters could disconnect from the patient’s fluid line.
According to the FDA, the resulting leak could lead to a dangerous loss of cerebrospinal fluid as well as carry the potential to introduce infections into the nervous system. The agency said it had received 26 reports of related injuries but no reports of death.
The recall covers Medtronic Neurosurgery’s Duet external drainage and monitoring system, designed for short-term unloading of the skull or lumbar puncture sites, as well as sample collection.
The closed system, also used internationally, relies on gravity to collect CSF or blood through a drip chamber. It is also employed in patients undergoing surgery to repair an abdominal aortic aneurysm and to absolve subsequent symptoms such as short-term lower paralysis.
Jan. 23, Medtronic sent customers a recall letter urging them to quarantine impacted products—including model numbers 46913, 46914, 46915, 46916 and 46917—and to return any unused equipment to the manufacturer.
The company said any system currently being used with a patient should be left in place if it is working correctly; however, a recalled or leaking Duet system should be swapped out using a sterile technique and discarded.