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Recall Observatory FDA recall evidence

Device product

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.

Z-1676-2014

April 21, 2014

Class II

Product summary

Firm
Aesculap, Inc.
Event
Event 68091
Status
Terminated
Classification
Class II
Quantity
48
Official record key
device-enforcement:Z-1676-2014

Official wording

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

Code information: Catalog No: FV431T, FV434T, FV433T, FV459T, FV078P, FV494T, FV676T, FV324T Lot No: 4505150452,4505156642,4505164365,4505134636,4505150384,4505156634,4505246780,4505394315,4505150371,4505174213,4505187583,4505366616,4505134635,4505187582,4505134629,4505212089,4505199667,4505150340,4505171900,4505168804

Distribution pattern: US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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