Device product
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Z-0814-2015
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 69741
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4
- Official record key
device-enforcement:Z-0814-2015
Official wording
Reason: Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.
Code information: Catalog No: FV660T Lot No: 4506022655
Distribution pattern: Distributed in OK, and WI.
Derived failure modes
-
Unknown
Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.