Z-2190-2014Class II

Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories

Name: Z-2190-2014 Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories
Creator: Codman & Shurtleff, Inc.
Published: 2014-07-03
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2014-07-03 / Terminated / root cause: design

FDA source

Codman & Shurtleff, Inc. began a recall of Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable... on 2014-07-03. FDA classified it as Class II and gives the reason as "To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU)". 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-2190-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-03
Posted: 2014-08-12
Terminated: 2017-01-30
Recalling firm: Cerenovus, Inc.
Product: Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories; Product Code: 82-8806 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.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Root cause tag: design
FDA root cause: Device Design
Action: Codman Neuro sent an Urgent Medical Device Safety Notification dated July 17, 2014, to clinicians who use the device. The notification clarifies the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). Consignees are also asked to complete the enclosed Acknowledgement Form and fax the completed form to 1-888-239-1305. For questions or concerns regarding this notification, consignees are instructed to contact their local Codman Neuro Representative or Scientific and Medical Affairs at [email protected] or (866) 685-7325. For questions regarding this recall call 508-828-2726.
Quantity in commerce: 9,498 devices total
Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
Product codes and lots: Lot Numbers: CMBC2Z, CMBCPR, CMCC2T, CMDB7C, CMDBHC, CMJC49, CMJCMD, CMLBLZ, CMMB14, CNDBCY, CNDCV2, CNJCFT, CNKBHS, CNLB57, CNMDNL, CNNCWD, CNPB1Z, CPBB3J, CPBDBB, CPCCMO, CPDBYK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2190-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2184-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-12
Z-2185-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-12
Z-2186-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-12
Z-2187-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-12
Z-2188-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-12
Z-2189-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-12
Z-2190-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-12
Z-2191-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-12

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