Device 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.
Z-0399-2014
Product summary
- Event
- Event 66882
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0399-2014
Official wording
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.
Code information: Lot Numbers: D22311; D37565.
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.
Derived failure modes
-
Unknown
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.