Z-1676-2014Class II

Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System...

Name: Z-1676-2014 Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System...
Creator: Aesculap, Inc.
Published: 2014-04-21
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2014-04-21 / Terminated / root cause: design

FDA source

Aesculap, Inc. began a recall of Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the... on 2014-04-21. FDA classified it as Class II and gives the reason as "AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1676-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-21
Posted: 2014-06-02
Terminated: 2014-10-20
Recalling firm: Aesculap Inc
Product: 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.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 48
Distribution: US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
Product codes and lots: Catalog No: FV431T, FV434T, FV433T, FV459T, FV078P, FV494T, FV676T, FV324T Lot No: 4505150452,4505156642,4505164365,4505134636,4505150384,4505156634,4505246780,4505394315,4505150371,4505174213,4505187583,4505366616,4505134635,4505187582,4505134629,4505212089,4505199667,4505150340,4505171900,4505168804

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1676-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1676-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

Product code JXG

K031303Class IIAesculap-Miethke Shunt System Gravity Assisted Valve (Gav)Aesculap, Inc. / cleared 2003-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)