Integra LifeSciences recalls specific CODMAN CERTAS Plus Programmable Valve models due to incorrect labeling on internal and external labels, which may lead to improper use.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Integra LifeSciences is recalling certain CODMAN CERTAS Plus Programmable Valve Right Angle Valves (model 828820) because they were distributed with incorrect product descriptions on both internal and external labels. This labeling error could lead to improper use of the device, which is intended for hydrocephalus treatment.
The device is designed to provide constant intraventricular pressure and drainage of cerebrospinal fluid for hydrocephalus management. Incorrect labeling could lead to improper use, potentially causing complications during treatment.
Patients who have received the specific CODMAN CERTAS Plus Programmable Valve Right Angle Valve (model 828820) with incorrect labeling on internal and external labels are affected. Medical professionals who use this device for hydrocephalus treatment are most at risk.
Check for the model number 828820 on the device. Look for the lot number 7415567 and verify the internal and external labels match the correct product description.
Verify the internal and external labels match the correct product description for model 828820.
The model number is 828820.
The lot number is 7415567.
Check if the internal and external labels match the correct product description for model 828820.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0979-2025 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0979-2025 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
