Z-1012-2015Class II

Miethke Shunt System accessories

Name: Z-1012-2015 Miethke Shunt System accessories
Creator: Aesculap, Inc.
Published: 2014-12-17
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2014-12-17 / Terminated / root cause: labeling and UDI

FDA source

Aesculap, Inc. began a recall of Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain... on 2014-12-17. FDA classified it as Class II and gives the reason as "Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This...". 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-1012-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-17
Posted: 2015-01-26
Terminated: 2016-12-13
Recalling firm: Aesculap Inc
Product: Miethke Shunt System accessories Product Usage: - 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: Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Aesculap sent an Important Correction and Removal and Field Safety Notification letter, dated December 17, 2014, to all affected customers. The letter identiifed the affected product, problem, and actions to be taken. Customers were requested to remove from inventory and contact Aesculap regarding return of the affected devices and acknowledgement form.
Quantity in commerce: 772
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1012-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1012-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-26

Product code JXG

K120559Class IIAesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. / cleared 2012-05-24

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)