Z-0397-2014Class II

CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured...

Name: Z-0397-2014 CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured...
Creator: Medtronic Neurosurgery
Published: 2013-11-18
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2013-11-18 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Neurosurgery began a recall of CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized... on 2013-11-18. FDA classified it as Class II and gives the reason as "Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies". 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-0397-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-18
Posted: 2013-11-26
Terminated: 2014-02-06
Recalling firm: Medtronic Neurosurgery
Product: CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Medtronic Neurosurgery sent an Urgent Medical Device Recall letter dated November 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to provide a copy of the letter to all those who need to be aware of the matter within their organization or to any organization where the potentially affected product may have been transferred. Customers with questions were instructed to call 805-571-8725.
Quantity in commerce: 288 units total (147 units in US)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.
Product codes and lots: Lot Numbers: Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539. Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540. Catalog No. 46026: D35572; D39583.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0397-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0397-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26
Z-0398-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26
Z-0399-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

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