Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Strata II Shunt Assembly Kit Recalled by Medtronic Neurosurgery Due to Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta...
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 Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
Quantity: 5 units
Why Was This Recalled?
Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
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