PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: December 24, 2014 Initiated: November 11, 2014 #Z-0814-2015

Product Description

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 for Recall

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.

Details

Recalling Firm
Aesculap, Inc.
Units Affected
4
Distribution
Distributed in OK, and WI.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Aesculap, Inc.. Units affected: 4.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 24, 2014. Severity: Low. Recall number: Z-0814-2015.