Codman & Shurtleff, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2189-2014)

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 - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 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 Classification:

Class II

Date Initiated: July 3, 2014

Date Posted: August 20, 2014

Recall Number: Z-2189-2014

Event ID: 68837

Reason for Recall:

To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Status: Terminated

Product Quantity: 9,498 devices total

Code Information:

Lot Numbers: CMBC2Y, CMDCN9, CMJC48, CMLC6D, CMNBFF, CMNCDY, CNCB6M, CNCCLB, CNCCZ4, CNDBRG, CNDCNB, CNHC8M, CNJC4P, CNKCL4, CNLCL1, CNMB8Y, CNMDMO, CNNDHY, CNPCLZ, CPBC99, CPBCRZ, CPCC27, CPDBYJ, CPDCKL

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated