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.
FDA Recall Z-1676-2014 · Posted 2014-06-02
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Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeJXG
Date Initiated2014-04-21
Date Terminated2014-10-20
Product Quantity48
Reason for Recall
AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Firm Action
Aesculap sent an Important Correction & Removal recall letter dated April 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
An Aesculap Sales Representative will contact you to schedule return of any affected inventory and replace your product. Please complete the attached Inventory Sheet which is necessary to comply with FDA regulations. When completing the inventory sheet, please be sure to fill in the quantity
being returned. If you cannot locate the product, please provide an explanation as to why the inventory will not be returned (discarded, etc.).
AIC (USA) appreciates your cooperation on this matter and apologizes for the inconvenience this may cause. Thank you for your patience and continued support of this product. Please contact (610) 984-9414 with any questions.
Root Cause
Device Design
Distribution Pattern
US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
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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