Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Medtronic Duet External Drainage and Monitoring System Recalled by Medtronic Neurosurgery Due to Potential for catheter disconnection from the patient line...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neurosurgery directly.
Affected Products
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Quantity: 11,840 units
Why Was This Recalled?
Potential for catheter disconnection from the patient line stopcock connectors.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Neurosurgery
Medtronic Neurosurgery has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report