Reported Feb 4, 2015 · Terminated

Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from…

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?

  • Miethke
  • Shunt System accessories Product Usage- The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum
Lot codes and dates
  • material numbers
    • FV400T
    • FV401T
    • FV402T
    • FV403T
    • FV404T
    • FV405T
    • FV406T
    • FV407T
    • FV408T
    • FV409T
    • FV499T
    • FV790T
    • FV791T
    • FV792T
    • FV793T
    • FV794T
    • FV795T
    • FV796T
Amount recalled
772

Where it was sold

  • Nationwide

Why it was recalled

Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).

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 Dec 13, 2016 · Data as of Sep 19, 5:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.