Reported Jun 11, 2014 · Terminated

Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is…

Aesculap, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aesculap, Inc. · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217

Is this the product you have?

  • 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.
Lot codes and dates
  • 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
Amount recalled
48

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 20, 2014 · Data as of Sep 19, 6:05 PM UTC

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