Medtronic Recall Of Duet External Drainage and Monitoring System Catheter Tubing
FDA IDENTIFIES AS CLASS I RECALL; POTENTIAL FOR CATHETER DISCONNECTION ASSOCIATED WITH PRODUCT DISTRIBUTED 5/3/21 - 1/9/24
The U.S. Food and Drug Administration has issued a Class I recall for Medtronic Duet External Drainage and Monitoring System Catheter Tubing. This is the most serious type of recall.
The systems are often utilized for temporary drainage of cerebrospinal fluid in patients who have had certain types of procedures; for example, a descending thoracic aortic aneurysm, or those patients who had TAA/TAAA repair surgery and develop symptoms such as paraplegia.
Risk of harm to patients may occur if a tubing disconnection occurs. These risks include cerebrospinal fluid leakage, infections, over drainage of cerebrospinal fluid, and abnormality of the ventricles (as noted in the FDA documentation; link below).
An uncontrolled over drainage of cerebral spinal fluid could lead to neurologic injuries and even death.
What Products Does This Recall Involve?
This Recall Involves: Medtronic Duet External Drainage and Monitoring System Catheter Tubing
The Product Codes: PCB
Model Numbers: 46913, 46914, 46915, 46916, and 46917
Distributed: May 3, 2021 to January 9, 2024
What to Do If You Use These Products?
Medtronic sent a notice to all affected consumers on January 23, 2024 — “Urgent Medical Device Recall.”
This letter requested that customers should follow all instructions provided.
The letter and the full recall alert can be found here: