The FDA has issued a Class I recall, the most serious form, for Medtronic’s Duet External Drainage and Monitoring System Catheter Tubing due to the risk of catheter disconnection from the patient line stopcock connectors, which could lead to serious injuries or death. The recall affects product codes PCB, model numbers 46913 to 46917, with 45,176 devices recalled in the U.S. between May 3, 2021, and January 9, 2024. The Duet System is used for temporary cerebrospinal fluid (CSF) drainage or sampling, particularly after specific aortic aneurysm surgeries or in cases of developing symptoms like paraplegia post-surgery.
The recall was initiated because of the potential harm from tubing disconnection, including infections, CSF leakage, over drainage, and ventricle abnormalities, with 26 reported injuries but no deaths. The device is recommended for neurosurgeons, neurologists, and medical professionals involved in CSF drainage and monitoring.
Medtronic has advised customers to quarantine and return any unused and non-expired products, check all components for damage, secure connections, and, if a disconnection is detected in a patient-connected device, switch to an alternative device using sterile techniques. However, if a connected device is working as intended, it’s recommended not to remove or replace it. The company has asked for the completion and return of a Customer Confirmation Form by affected customers and advised them to maintain a record of the notice and distribute it to relevant parties. For further assistance, U.S. customers can contact Medtronic at 1-800-874-5797.