CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
Codman Certas Plus Programmable Valve Right Angle Valve Only recalled
Integra LifeSciences is recalling Codman Certas Plus Programmable Valve Right Angle Valve Only, distributed nationwide in the US. The recall was initiated on 16 Dec 2024 and the FDA has classified it as Class II.
Check your package
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-0979-2025
- FDA event ID
- 95951
- Recalling firm
- Integra LifeSciences, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2024
- FDA classified
- 17 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 16 Dec 2024 | Recall initiated by company | |
| 17 Jan 2025 | Classified by FDA | +32 days |
| 29 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Where it was distributed
US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
Nationwide ArizonaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaIndianaMassachusettsMichiganMinnesotaNorth CarolinaNebraskaNew JerseyNew YorkOhioOregonRhode IslandSouth CarolinaTexasUtah
Questions about this recall
Is Codman Certas Plus Programmable Valve Right Angle Valve Only recalled?
Yes. Integra LifeSciences recalled Codman Certas Plus Programmable Valve Right Angle Valve Only on 16 Dec 2024. The recall is Class II and its status is Ongoing. Recall number Z-0979-2025.
Why was it recalled?
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Which lots are affected?
UDI-DI: 10381780535997. Lot Number: 7415567.
Where was it sold?
US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
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.
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