CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report

Codman Certas Programmable Valve In Line Valve only recalled

Codman & Shurtleff is recalling Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product, distributed nationwide in the US. The recall was initiated on 16 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Codes: CNMCDP CNMDM2 CNMDNG CNFCVJ CNHB96 CNHC8L CNHCZM CNHCZT CNJBWW CNJBWY CNJCFP CNJCG9 CNKB0R CNKBTR CNKCL0 CNKCL2 CNLBR2 CNLBZD CNMCDV CNMDM3 CNNCWC CNPB1W CNPBRJ CNPCLP CPBB39 CPBBGN CPBC98 CPBCKR CPBCKT CPCBG7 CPCCBG CPDBYH CPDC09 CPDCC4 CNBB13 CNCB6L CNDB8B CNDBVZ CNDCM9 CNHC8J CNHCKG CNJC39 CNJC4H CNJC4J CNJCB0 CNDCM8 CNKB42 CNFCVH CNHCZH CNJB98 CNLCW4 CNMBFK CNMCDW CNMDNH CNNCWH CNNDH2 CNNDH3 CNPB1V CPBB3H CPBCR0 CPCBG6 CPCCBD CPCCBF CPDBYG CPDCC6 CMMB1L CMBC2W CMDBHB CMDDJP CMDDJR CMKB22 CMLCKR CMMCR5 CMNBFD CMNCVP CMNCYM CMPB95 CMPBMD CNBBCZ CNCB4R CNCB61 CNMCDR CPCCMW

Quantity recalled1481 units

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-0861-2014
FDA event ID: 65179
Recalling firm: Codman & Shurtleff, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 16 May 2013
FDA classified: 28 Jan 2014
Reported: 5 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

16 May 2013	Recall initiated by company
28 Jan 2014	Classified by FDA	+257 days
5 Feb 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

Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 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.

Where it was distributed

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.

Nationwide

Questions about this recall

Is Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product recalled?

Yes. Codman & Shurtleff recalled Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product on 16 May 2013. The recall is Class II and its status is Terminated. Recall number Z-0861-2014.

Why was it recalled?

Codman Certas Programmable Valves used for hydrocephalus may not operate properly

Which lots are affected?

Lot Codes: CNMCDP CNMDM2 CNMDNG CNFCVJ CNHB96 CNHC8L CNHCZM CNHCZT CNJBWW CNJBWY CNJCFP CNJCG9 CNKB0R CNKBTR CNKCL0 CNKCL2 CNLBR2 CNLBZD CNMCDV CNMDM3 CNNCWC CNPB1W CNPBRJ CNPCLP CPBB39 CPBBGN CPBC98 CPBCKR CPBCKT CPCBG7 CPCCBG CPDBYH CPDC09 CPDCC4 CNBB13 CNCB6L CNDB8B CNDBVZ CNDCM9 CNHC8J CNHCKG CNJC39 CNJC4H CNJC4J CNJCB0 CNDCM8 CNKB42 CNFCVH CNHCZH CNJB98 CNLCW4 CNMBFK CNMCDW CNMDNH CNNCWH CNNDH2 CNNDH3 CNPB1V CPBB3H CPBCR0 CPCBG6 CPCCBD CPCCBF CPDBYG CPDCC6 CMMB1L CMBC2W CMDBHB CMDDJP CMDDJR CMKB22 CMLCKR CMMCR5 CMNBFD CMNCVP CMNCYM CMPB95 CMPBMD CNBBCZ CNCB4R CNCB61 CNMCDR CPCCMW

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

More recalls from Codman & Shurtleff

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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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