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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: August 12, 2014
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Affected Products

Product: Codman Certas - In Line Valve Only; Product Code: 82-8800 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.

Lot Numbers: CLNCB1, CMBBP1, CMBCPN, CMCBWG, CMCC2V, CMDCN8, CMDDJN, CMGB8H, CMI<B21, CMJCL8, CMJCPW, CMMCGR, CMNBFB, CMNBZJ, CMNC8T, CMNCYL, CMPB4V, CNBBCV, CNCB6W, CNCCPF, CNDBCW, CNDBRH, CNDCJ2, CNFCK7, CNGBG0, CNGBI<2, CNGBRY, CNHB95, CNHCKH, CNHCZN, CNJBW5, CNJBWZ, CNJC38, CNJC4I<, CNJCD3, CNJCFR, CNJCMN, CNKBWP, CNKCC8, CNKCL3, CNLBR6, CNLCL3, CNLCW3, CNNCWF, CNNDCK, CNPB1R, CNPB1T, CNPBML, CNPBRH, CNPCLR, CPBB3G, CPBC96, CPBCCR, CPBCRV, CPCBG8, CPCBG9, CPCCBH, CPCCM1, CPCCMK, CPCCMZ, CPDBYC, CPDC07, CPDCC7, CPFBKP

Lot Numbers:
Numbers
Product: Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 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.

Lot Numbers: CMBBP2, CMCBLG, CMDBHG, CMFBB8, CMHDFW, CMJCPY, CMLBLW, CMLCKP, CMMBCY, CMMC3F, CMNBFC, CMNCDW, CMPB96, CNCCLK, CNJBWO, CNJC4B, CNJC4W, CNKBWN, CNKCL1, CNLBR3, CNLBZF, CNMDM1, CNNCPL, CNNDH4, CNPBRM, CPBBGP, CPBC97, CPBCRW, CPBCVD, CPCBHB, CPCCMP, CPDBYD, CPDBYF

Lot Numbers:
Numbers
Product: Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 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.

Lot Numbers: CMBCB2, CMCBLH, CMDBHF, CMGBL5, CMJCMC, CMLBLY, CMNBZK, CNDCV1, CNHC8N, CNI<B41, CNLBR5, CNMB2Z, CNMDNN, CNNCWG, CNPB1Y, CNPCLT, CPBCRY, CPDBM1, CPFBK1

Lot Numbers:
Numbers
Product: Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 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.

Lot Numbers: CLPCM9, CMBBB2, CMBBB3, CMDBHD, CMDCN7, CMDDJT, CMFBNK, CMFBNL, CMNBZG, CNDCP3, CNGBK5, CNHCZP, CNJB1F, CNJC4R, CNJCMP, CNKBOY, CNLCLO, CNMCYY, CNMDNJ, CNNDHO, CNPBRK, CNPCLW, CPBBGR, CPCCBC, CPCCML, CPDCC2

Lot Numbers:
Numbers
Product: Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 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.

Lot Numbers: CMBC2W, CMDBHB, CMDDJP, CMDDJR, CMKB22, CMLCKR, CMMB1L, CMMCR5, CMNBFD, CMNCVP, CMNCYM, CMPB95, CMPBMD, CNBB13, CNBBCZ, CNCB4R, CNCB61, CNCB6L, CNDB8B, CNDBVZ, CNDCM8, CNDCM9, CNFCVH, CNFCVJ, CNHB96, CNHC8J, CNHC8L, CNHCKG, CNHCZH, CNHCZM, CNHCZT, CNJB98, CNJBWW, CNJBWY, CNJC39, CNJC4H, CNJC4J, CNJCBO, CNJCFP, CNJCG9, CNKB42, CNKBOR, CNKBTR, CNKCLO, CNKCLZ, CNLBR2, CNLBZD, CNLCW4, CNMBFK, CNMCDP, CNMCDR, CNMCDV, CNMCDW, CNMDM2, CNMDM3, CNMDNG, CNMDNH, CNNCWC, CNNCWH, CNNDH2, CNNDH3, CNPB1V, CNPB1W, CNPBRJ, CNPCLP, CPBB39, CPBB3H, CPBBGN, CPBC98, CPBCKR, CPBCKT, CPBCRO, CPCBG6, CPCBG7, CPCCBD, CPCCBF, CPCCBG, CPCCMW, CPDBYG, CPDBYH, CPDC09, CPDCC4, CPDCC6

Lot Numbers:
Numbers
Product: 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.

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

Lot Numbers:
Numbers
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.

Lot Numbers: CMBC2Z, CMBCPR, CMCC2T, CMDB7C, CMDBHC, CMJC49, CMJCMD, CMLBLZ, CMMB14, CNDBCY, CNDCV2, CNJCFT, CNKBHS, CNLB57, CNMDNL, CNNCWD, CNPB1Z, CPBB3J, CPBDBB, CPCCMO, CPDBYK

Lot Numbers:
Numbers
Product: Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 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.

Lot Numbers: CLPCNB, CMBCPT, CMCC2W, CMDB6L, CMDDJV, CMI<B24, CMLCKN, CMMC3H, CMMCGV, CMNBZH, CNBB11, CNCB6N, CNCCLH, CNCCU, CNCCZ2, CNCCZ3, CNDB69, CNDB8C, CNDBRJ, CNDCVO, CNGBK4, CNHCZR, CNJB1G, CNJC4T, CNJCMR, CNKBZD, CNLBVM, CNLBZC, CNMBFL, CNMBFM, CNMDNK, CNNDH1, CNPBRL, CNPCLV, CPBBGT, CPBCR3, CPBCR4, CPCBHC, CPCBHD, CPCCMN, CPDBYL, CPDCC3

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68837
Status: Resolved
Manufacturer: Codman & Shurtleff, Inc.
Manufactured In: United States
Units Affected: 8 products (9,498 devices total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.