Z-0814-2015Class III

Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal...

Name: Z-0814-2015 Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal...
Creator: Aesculap, Inc.
Published: 2014-11-11
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2014-11-11 / Terminated / root cause: labeling and UDI

FDA source

Aesculap, Inc. began a recall of Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain... on 2014-11-11. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0814-2015
Classification: Class III
Status: Terminated
Initiated: 2014-11-11
Posted: 2014-12-16
Terminated: 2015-06-09
Recalling firm: Aesculap Inc
Product: 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.
Product code: JXG Shunt, Central Nervous System And Components
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 4
Distribution: Distributed in OK, and WI.
Product codes and lots: Catalog No: FV660T Lot No: 4506022655

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0814-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0814-2015	Class III	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16

Product code JXG

K110206Class IIAesculap- Meithke Shunt SystemAesculap, Inc. / cleared 2011-10-27

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)