Medtronic Issues Class I Recall for Duet External Drainage and Monitoring System Catheters Over Risk of Disconnection Leading to Potential Death
Medtronic
Medical Device Manufacturer
On March 7, the U.S. Food and Drug Administration (FDA) classified the recall of Medtronic's Duet External Drainage and Monitoring System catheter line as a Class I recall, which is the most serious level.
Medtronic Neurosurgery initiated a recall on January 22. The devices involved45,176According to the FDA,The models involved include 46913, 46914, 46915, 46916, and 46917.
Product Name:Medtronic Duet External Drainage and Monitoring System Catheter
Product Code: PCB
Model: 46913, 46914, 46915, 46916, and 46917
Distribution Date: May 3, 2021 to January 9, 2021
Number of Devices Recalled in the U.S.: 45,176
Company Initiation Date: January 22, 2024
Equipment Usage
DUET External Drainage and Monitoring System (EDMS) is used for the temporary drainage of cerebrospinal fluid (CSF) or cerebrospinal fluid sampling in individuals with the following conditions:
Surgery for Open Descending Thoracic Aortic Aneurysm (Open TAA) or Open Thoracoabdominal Aortic Aneurysm (Open TAAA).
Patients who have undergone TAA/TAAA repair surgery and developed symptoms such as paraplegia.
Reason for Recall
Medtronic Neurosurgery is recalling the Duet External Drainage and Monitoring System (EDMS) catheter because the catheter may disconnect from the patient line stopcock connector.
Medtronic Recalls Duet EDMS Catheter Tubing Due to Risk of Detachment from Patient Line Stopcock Connector
Twenty-six people were reported injured, and no deaths have been reported so far.
Who Might Be Affected
Neurosurgeons, neurologists, and other healthcare professionals are involved in the management of patients' cerebrospinal fluid (CSF) drainage and monitoring using the Medtronic Duet External Drainage and Monitoring System.
Individuals who undergo certain surgeries or experience neurological symptoms post-surgery and require the use of the Medtronic Duet External Drainage and Monitoring System for temporary drainage and monitoring of cerebrospinal fluid (CSF).
Follow-up Handling Method
On January 23, 2024, Medtronic issued an urgent medical device recall notice to all affected customers.
The letter requests the customer to:
Identify and isolate any unused affected products.
Return all unused and unexpired products in inventory to Medtronic according to the instructions included in the customer confirmation form.
Check all components for damage and ensure all connections are secure and leak-free.
If the patient is currently connected to the affected Duet EDMS and a leak or disconnection is detected, the device should be replaced with a new alternative device using sterile technique.
It is not recommended to remove or replace the Duet system device that has been connected to the patient and found to function as intended after inspection.
Dispose of any affected products according to the policies and practices of the medical institution.
Fill out the customer confirmation form included in the letter to confirm receipt of this information.
Distribute this notice to all who should be aware, or to any organization to which the potentially affected devices may have been transferred.
Medtronic requests healthcare provider customers to identify and isolate any unused affected products. They should inspect all components for damage and ensure all connections are secure and leak-free. For patients experiencing leaks or detachment with the Duet EDMS, a replacement with a new alternative device should be made using sterile technique. Medtronic recommends not replacing the device if the Duet EDMS is functioning as expected.
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