Integra LifeSciences recalls CereLink ICP Extension Cable Model 826845 due to potential out of range readings. Affected units sold with Codman CereLink ICP monitors.
Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.
Integra LifeSciences is recalling CereLink ICP Extension Cables (Model 826845) that may cause inaccurate intracranial pressure readings. This could lead to incorrect medical decisions if used with Codman CereLink ICP monitors.
The extension cable may produce out of range readings when used with Codman CereLink ICP monitors. This could lead to incorrect medical decisions if the readings are not properly interpreted by healthcare providers.
Patients using Codman CereLink ICP monitors with the recalled extension cable (Model 826845) are affected. Healthcare providers using these monitors for intracranial pressure monitoring are most at risk.
Check for the model number 826845 on the extension cable. The cable is used with Codman CereLink ICP monitors (model numbers 826820 or 826820P). All lots distributed.
Verify the extension cable model number is 826845.
Reach out to Integra LifeSciences for further assistance or to confirm if a replacement is needed.
The recall addresses potential out of range readings when used with Codman CereLink ICP monitors, which could lead to incorrect medical decisions.
Yes, Integra LifeSciences is implementing a design change to the extension cable to address the out of range readings issue.
Look for the model number 826845 on the extension cable, which is used with Codman CereLink ICP monitors (model numbers 826820 or 826820P).
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0548-2024 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0548-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
