The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• Product Names: Medtronic Duet External Drainage and Monitoring System Catheter Tubing
• Product Codes: PCB
  • Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Cather (fda.gov)
  • Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Cather (fda.gov)
  • Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, (fda.gov)
  • Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites (fda.gov)
  • Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter (fda.gov)
• Model Numbers: 46913, 46914, 46915, 46916, and 46917
• Distribution Dates: May 3, 2021 to January 9, 2024
• Devices Recalled in the U.S.: 45.176
• Date Initiated by Firm: January 22, 2024

Device Use

End of
Translation

The DUET External Drainage and Monitoring System (EDMS) is used for temporary drainage of cerebrospinal fluid (CSF) or CSF sampling in people who have:

• Surgery for open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA).
• Had TAA/TAAA repair surgery and develop symptoms like paraplegia.

The system includes, a green-striped tube, stopcocks, a drip chamber, a pressure scale, needleless injection/CSF sampling sites, and a removable bag with measurements and an air vent. This system works by gravity, flowing CSF from an external lumbar catheter through the patient tube, into the drip chamber, and finally into the bag. It's suggested to use it with the Clear-Site Laser Level provided separately.

Reason for Recall

Medtronic Neurosurgery is recalling the Duet External Drainage and Monitoring System (EDMS) catheter tubing due to a potential for the catheter disconnection from the patient line stopcock connectors.

If a tubing disconnection occurs, potential harm to patients may include infections, cerebrospinal fluid leakage, over drainage of cerebrospinal fluid, and abnormality of the ventricles. Uncontrolled over drainage of cerebral spinal fluid could lead to neurological injury or death if the disconnection is undetected.

There have been 26 reported injuries. There have been no reports of death.

Who May be Affected

• Neurosurgeons, neurologists, and other medical professionals involved in managing cerebrospinal fluid (CSF) drainage and monitoring in patients using the Medtronic Duet External Drainage and Monitoring System
• People undergoing certain surgeries or those who may develop neurological symptoms post-surgery and require temporary drainage and monitoring of cerebrospinal fluid (CSF) using the Medtronic Duet External Drainage and Monitoring System

What to Do

On January 23, 2024, Medtronic sent all affected customers an Urgent Medical Device Recall.

The letter requested customers to:

• Identify and quarantine any unused impacted product(s).
  • Return all unused and non-expired product(s) in your inventory to Medtronic following the instructions that were included with the Customer Confirmation Form.
• Check all components for damage and that all connections are secure and leak-free.
  • If a patient is currently connected to an impacted Duet EDMS and a leak or disconnection is detected, the device should be changed to a new alternative device utilizing a sterile technique.
  • It is not recommended to remove or replace a Duet system device that is connected to a patient and has been examined and found to be working as intended.
• Dispose any impacted product in accordance with the healthcare facility's policies and practices.
• Complete the Customer Confirmation Form that was included in the letter, acknowledging receipt of this information.
• Distribute the notice to all who should be aware, or to any organization where the potentially affected devices have been transferred.
• Please maintain a copy of this notice in your records.

Contact Information

Customers in the U.S. with questions about this recall should contact Medtronic at 1-800-874-5797.

Additional Resources

• Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Cather (fda.gov)
• Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Cather (fda.gov)
• Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, (fda.gov)
• Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites (fda.gov)
• Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter (fda.gov)

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.