Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
REF 27219-5 X1 Recalled by Medtronic Neurosurgery Due to Neonatal Valves were manufactured with a ventricular catheter...
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
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.
Quantity: N/A
Why Was This Recalled?
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
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