Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
FDA Recall Z-0814-2015 · Posted 2014-12-16
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Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeJXG
Date Initiated2014-11-11
Date Terminated2015-06-09
Product Quantity4
Reason for Recall
Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.
Firm Action
An important correction & removal notification, dated November 11, 2014, was sent to consignees that identified the product, problem, and action to be taken. Consignees were asked to complete the distribution inventory sheet and return it. Aesculap sales representatives would be coordinating pick up of affected devices.
Root Cause
Labeling Change Control
Distribution Pattern
Distributed in OK, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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