FDA-Device2014-12-24Class III

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.

Aesculap, Inc.
Hazard

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.

Sold states
Distributed in OK, and WI.
Affected count
4
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0814-2015

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