Medtronic faces FDA Class I recall for post-op drainage device

The U.S. Food and Drug Administration has issued a Class I recall, the agency’s most serious, for a Medtronic device used to temporarily drain spinal fluid from patients after surgery for a thoracic aortic aneurysm.

Medtronic’s Duet External Drainage and Monitoring System Catheter Tubing carries the potential risk of the catheter becoming disconnected, which could cause infections or other problems for patients. According to the FDA, “uncontrolled overdrainage of cerebral spinal fluid could lead to neurological injury or death if the disconnection is undetected.” Medtronic faced a Class I recall for the same product in 2014 because of a similar issue.

There have been 26 reported injuries and no reported deaths in connection with the device’s defect. The recall, which the medical device manufacturing company initially issued Jan. 22, affects more than 45,000 devices. However, thoracic aortic aneurysms — which this device helps treat — are not common, affecting about six to 10 of every 100,000 people, according to the Cleveland Clinic.

Neurosurgeons, neurologists and other clinicians use the Duet device for patients recovering from surgery on an open descending thoracic aortic aneurysm or open descending thoraco-abdominal aortic aneurysm. Medtronic’s Urgent Medical Device Recall called for caregivers to “return all unused and non-expired product(s) in your inventory to Medtronic.”

“An investigation into this issue was initiated after receiving complaints. No serious neurological injuries or patient deaths have been reported,” Medtronic said in a statement. “Medtronic has ceased the distribution of affected products, is investigating the root cause and is communicating with regulatory agencies, patients and customers.”