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Recall Observatory FDA recall evidence

Device product

Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

Z-0989-2014

December 23, 2013

Class II

Product summary

Firm
Aesculap, Inc.
Event
Event 67174
Status
Terminated
Classification
Class II
Quantity
79
Official record key
device-enforcement:Z-0989-2014

Official wording

Reason: The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.

Code information: 4 lots: 4505268906, 4505336973, 4505408485, 4505238953

Distribution pattern: Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification