CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report

Inc.(AIC) Miethke Ventricular Catheter recalled by Aesculap

Aesculap is recalling Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke, distributed in 10 states. The recall was initiated on 21 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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

Quantity recalled48

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1676-2014
FDA event ID: 68091
Recalling firm: Aesculap, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 21 Apr 2014
FDA classified: 2 Jun 2014
Reported: 11 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Apr 2014	Recall initiated by company
2 Jun 2014	Classified by FDA	+42 days
11 Jun 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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

Connecticut Kansas Kentucky New York Pennsylvania Rhode Island South Carolina Tennessee Texas Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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