Medtronic Class 1 Recall of Duet Drainage Device

FDA has classified as Class 1 a Medtronic Neurology recall of its Duet External Drainage and Monitoring System due to the potential for catheter disconnection from patient line stopcock connectors. The device is used to drain cerebrospinal fluid (CSF) to reduce intracranial pressure and CSF volume in people who have surgery for open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA). It is also used in people who’ve had TAA/TAAA repair surgery and develop symptoms like paraplegia.

Medtronic describes the device as using gravity to drain CSF from a patient’s ventricles or lumbar space to an external drainage receptacle. “The Duet’s catheter is surgically attached to the patient before it is attached to the drainage system,” it says. Through an opening in the patient’s skull or lumbar region, a catheter is inserted into the ventricle or the lumbar subarachnoid space, and then it is attached to the drainage system.