Medtronic Neurosurgery has issued a Class I recall affecting 45,176 Duet external drainage and monitoring system catheter tubing following 26 reported injuries.
The recall impacts five product models, according to a March 7 FDA alert. The recall was initiated on Jan. 22.
The Duet system is used for temporary drainage of cerebrospinal fluid or CSF sampling in people who have surgery for open descending thoracic aortic aneurysm or open descending thoraco-abdominal aortic aneurysm, or for those who have had TAA/TAAA repair surgery and develop symptoms like paraplegia.
Medtronic Neurosurgery is recalling the Duet external drainage and monitoring system catheter tubing due to a potential for the catheter disconnection from the patient line stopcock connectors.
So far, 26 injuries have been reported from the system, but no deaths.