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Recall Observatory FDA recall evidence

Device product

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.

Z-1012-2015

December 17, 2014

Class II

Product summary

Firm
Aesculap, Inc.
Event
Event 70086
Status
Terminated
Classification
Class II
Quantity
772
Official record key
device-enforcement:Z-1012-2015

Official wording

Reason: 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).

Code information: material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T

Distribution pattern: Worldwide Distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).