Integra LifeSciences recalls Cerelink ICP Monitor model 826820 due to potential progressive decline in observed ICP readings during use. Affected users should contact the company for details.
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Integra LifeSciences is recalling its Cerelink ICP Monitor model 826820 because it may show decreasing pressure readings over time. This could lead to inaccurate medical monitoring, which is serious for patients using the device.
The monitor may show progressively lower readings over time, which could result in inaccurate blood pressure or fluid pressure measurements. This might lead to incorrect medical decisions if the device is used for critical monitoring.
Patients using the Cerelink ICP Monitor for medical pressure monitoring are most at risk. The device is intended for use with specific medical systems.
Check for the model number 826820 on the Cerelink ICP Monitor. The device is intended for use as an interface between pressure transducers and medical monitoring systems.
Look for the model number 826820 on the Cerelink ICP Monitor.
The recall is due to a potential progressive decline in observed ICP readings during use, which could lead to inaccurate medical monitoring.
The recall record does not specify a remedy, so contact Integra LifeSciences for further instructions.
The device may show decreasing readings over time, which could affect accuracy, but the recall record does not indicate immediate danger.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0124-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0124-2020 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.
