FDA Device recall Z-0399-2014
Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848 by Medtronic Neurosurgery, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0399-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-18 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Lot Numbers: D22311; D37565. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Medtronic Neurosurgery recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0399-2014%22
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