FDA Device recall Z-0814-2015
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral vent…
- FDA Device
- Class III
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class III recall of Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral vent… by Aesculap, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0814-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-11-11 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap |
| Distribution | OK, WI |
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.
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.
Identifiers
| code_info | Catalog No: FV660T Lot No: 4506022655 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0814-2015%22
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