FDA-Device2014-06-11Class II

Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

Aesculap, Inc.
Hazard

AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.

Sold states
US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
Affected count
48
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1676-2014

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