Medtronic Neurosurgery is recalling 45,176 drainage systems because catheters might disconnect from patient line stopcock connectors. There have been 26 reported injuries, the FDA said March 7.
Six models of the Medtronic Duet External Drainage and Monitoring System Catheter Tubing are being pulled from the market. The system is used to temporarily drain or obtain samples of cerebrospinal fluid. It is employed during surgeries for open descending thoracic aortic aneurysm and open descending thoraco-abdominal aortic aneurysm, plus post-surgery patients who develop paraplegia.
Catheter tubing disconnections can cause infections, cerebrospinal fluid leakage, excess drainage of cerebrospinal fluid, abnormality of the ventricles, neurological injury or death, the FDA said.
Medtronic notified customers in late June about the issue. No deaths have been reported.