Z-1468-2014Class II

CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve...

Name: Z-1468-2014 CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve...
Creator: Codman & Shurtleff, Inc.
Published: 2013-12-13
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2013-12-13 / Terminated / root cause: manufacturing process

FDA source

Codman & Shurtleff, Inc. began a recall of CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and... on 2013-12-13. FDA classified it as Class II and gives the reason as "Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves". 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-1468-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-13
Posted: 2014-04-17
Terminated: 2016-04-21
Recalling firm: Cerenovus, Inc.
Product: CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Codman Neuro issued notification packages dated 12/13/13 to Domestic Hospitals and international accounts. Specific letters and associated inclusion of the additional aids, include A) a valve setting verification guide with instructions for use with x-ray images, and B) a plastic valve cut out overlay). A response reply form was included to be completed and returned to confirm effectiveness of the notification.
Quantity in commerce: 9,445 units
Distribution: Nationwide Distribution.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1468-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1468-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)