PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 11, 2014 Initiated: April 21, 2014 #Z-1676-2014

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Aesculap, Inc.
Units Affected
48
Distribution
US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Aesculap, Inc.. Units affected: 48.
Why was this product recalled?
AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 11, 2014. Severity: Moderate. Recall number: Z-1676-2014.