CLASS II Device recall · Reported 20 Aug 2014 · FDA Enforcement Report

Codman Certas - In Line Valve only with Siphonguard¿ Device recalled

Codman & Shurtleff is recalling Codman Certas - In Line Valve only with Siphonguard¿ Device, distributed in 43 states. The recall was initiated on 3 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled9,498 devices total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2188-2014
FDA event ID: 68837
Recalling firm: Codman & Shurtleff, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 3 Jul 2014
FDA classified: 12 Aug 2014
Reported: 20 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

3 Jul 2014	Recall initiated by company
12 Aug 2014	Classified by FDA	+40 days
20 Aug 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 68837

Reported	Class	Recall	Company	Reason	Where
20 Aug 2014	CLASS II	Codman Certas - In Line Valve Only recalled by Codman & Shurtleff	Codman & Shurtleff	Other	43 states
20 Aug 2014	CLASS II	Codman Certas - In Line Valve with Siphonguard¿ recalled	Codman & Shurtleff	Other	43 states
20 Aug 2014	CLASS II	Codman Certas - In Line Valve with Siphonguard¿ Device recalled	Codman & Shurtleff	Packaging Defects	43 states
20 Aug 2014	CLASS II	Codman Certas - In Line Valve with Catheter and Accessories recalled	Codman & Shurtleff	Other	43 states
20 Aug 2014	CLASS II	Codman Certas - In Line Valve with Siphonguard¿ Device recalled	Codman & Shurtleff	Other	43 states
20 Aug 2014	CLASS II	Codman Certas - In Line Valve with Unitized Catheter and Accessories recalled	Codman & Shurtleff	Other	43 states
20 Aug 2014	CLASS II	Codman Certas - In line Valve recalled by Codman & Shurtleff	Codman & Shurtleff	Packaging Defects	43 states

More recalls from Codman & Shurtleff

All 59

Reported	Class	Recall	Company	Reason	Where
21 Aug 2019Device	CLASS II	Galaxy G3 Mini Microcoil Delivery System Product No: GLM915030 recalled	Codman & Shurtleff	Other	CA
3 Jun 2015Device	CLASS II	Codman 3000 Series Refill Set- Huber needles recalled	Codman & Shurtleff	Packaging Defects	Nationwide
29 Oct 2014Device	CLASS II	Codman EDS 3 Drainage System with Ventricular Catheter recalled	Codman & Shurtleff	Packaging Defects	Nationwide
29 Oct 2014Device	CLASS II	Codman EDS 3 Drainage System (no Ventricular Catheter) recalled	Codman & Shurtleff	Packaging Defects	Nationwide
29 Oct 2014Device	CLASS II	Codman Lumbar Drainage Catheter Kit II with EDS recalled	Codman & Shurtleff	Packaging Defects	Nationwide

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All 1,157

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