Z-0805-2013Class II

Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric...

Name: Z-0805-2013 Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric...
Creator: Aesculap, Inc.
Published: 2012-06-04
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2012-06-04 / Terminated / root cause: manufacturing process

FDA source

Aesculap, Inc. began a recall of Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous... on 2012-06-04. FDA classified it as Class II and gives the reason as "The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0805-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-04
Posted: 2013-02-12
Terminated: 2014-01-08
Recalling firm: Aesculap Inc
Product: Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components 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: The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Aesculap sent an Important Recall Notification letter dated June 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the contact their local sales representative or customer service department at 1-800-282-9000 to return the affected product. Customers were also instructed to complete the Inventory Sheet attached to the letter with the quantity being returned. If customers could not locate the affected product they should provide an explanation as to why the inventory will not be returned. Customers with questions should call 610-984-9251 or 610-984-9291. For questions regarding this recall call 1-800-234-9179, ext 5067.
Quantity in commerce: 11
Distribution: Nationwide Distribution including MI, PA and TX.
Product codes and lots: Lots 4503489878, 4503792749, 4503682927, 4503508385, 4503789879, 4503800248 and 4503682935.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0805-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0805-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-12

Product code JXG

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)