Codman & Shurtleff, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0863-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 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 Classification:

Class II

Date Initiated: May 16, 2013

Date Posted: February 5, 2014

Recall Number: Z-0863-2014

Event ID: 65179

Reason for Recall:

Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Status: Terminated

Product Quantity: 409 units

Code Information:

Lot Codes: CMJCMD CMBC2Z CMDB7C CMJC49 CMBCPR CMCC2T CMDBHC CMLBLZ CMMB14 CNDBCY CNDCV2 CNJCFT CNKBH6 CNLB57 CNMDNL CNNCWD CNPB1Z CPBB3J CPBDBB CPCCM0 CPDBYK

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated