Z-0864-2014Class II

Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and...

Name: Z-0864-2014 Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and...
Creator: Codman & Shurtleff, Inc.
Published: 2013-05-16
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2013-05-16 / Terminated / root cause: design

FDA source

Codman & Shurtleff, Inc. began a recall of Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The... on 2013-05-16. FDA classified it as Class II and gives the reason as "Codman Certas Programmable Valves used for hydrocephalus may not operate properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0864-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-16
Posted: 2014-01-29
Terminated: 2015-06-02
Recalling firm: Cerenovus, Inc.
Product: Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Root cause tag: design
FDA root cause: Device Design
Action: Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to [email protected]. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
Quantity in commerce: 746 units
Distribution: Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
Product codes and lots: Lot Codes: CLPCNB CMBCPT CMCC2W CMDB6L CMDDJV CMKB24 CMLCKN CMMC3H CMNBZH CNCB6N CNCCLJ CNCCZ3 CNDB8C CNDBRJ CNGBK4 CNHCZR CNJB1G CNJC4T CNJCMR CNKBZD CNLBVM CNLBZC CNMBFL CNNDH1 CNMBFM CNMDNK CNPBRL CNPCLV CPBBGT CNCCLH CNCCZ2 CNDB69 CNDCV0 CPBCR3 CPCBHC CPCBHD CPDCC3 CMMCGV CNBB11 CPBCR4 CPCCMN CPDBYL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0864-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0858-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28
Z-0859-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28
Z-0860-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28
Z-0861-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28
Z-0862-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28
Z-0863-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28
Z-0864-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28

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)