CereLink Intracranial Pressure Monitor Recall – A Critical Medical Device Failure

The CereLink Intracranial Pressure (ICP) Monitor, designed to measure brain pressure in critically ill patients, was recalled due to serious malfunctions that may have contributed to severe patient harm, including death.

What is the CereLink ICP Monitor?

The CereLink ICP Monitor is used in hospitals and intensive care units (ICUs) to measure intracranial pressure (ICP)—the pressure inside the skull. Increased ICP can be life-threatening and requires immediate intervention. The monitor helps doctors make critical treatment decisions. Decisions such as whether a patient needs surgery, medication, or other interventions to relieve brain swelling.

The device consists of a sensor that is implanted in the brain and a monitoring system that displays real-time pressure readings. Accurate readings are essential for guiding medical decisions and preventing complications like brain herniation, permanent brain damage, or death.

FDA classified the CereLink as a Class I recall,

In 2023, the FDA classified the CereLink recall as a Class I recall, its most serious designation, meaning the device posed a risk of severe injury or death. 

The recall came after reports of serious malfunctions in the device, including:

• Inaccurate Pressure Readings: Some monitors displayed sudden and unexpected pressure spikes, even when the patient’s brain pressure was stable.
• Device Failures: Some units stopped working entirely, leaving doctors without crucial data.
• False Readings Leading to Incorrect Treatment Decisions: Due to incorrect ICP readings, medical teams may have either failed to treat a dangerous rise in pressure or treated a non-existent issue, putting patients at risk.

Some of the potential consequences of a malfunctioning ICP monitor include:

• Brain swelling going untreated, leading to increased pressure and irreversible brain damage.
• Unnecessary brain surgeries performed based on false pressure readings, exposing patients to risks like infection, bleeding, or complications from anesthesia.
• Fatal brain herniation, where extreme pressure forces the brain to shift dangerously inside the skull. This cuts off blood flow and leading to death.

In critical care settings, incorrect pressure readings can be catastrophic, potentially causing brain damage or even fatal outcomes.

While there is no confirmation of any deaths as a direct result of the malfunctioning CereLink ICP Monitor, the risk remains extremely high for critically ill patients who rely on this technology.

Who Does This Recall Affect?

The recall primarily affects:

• Hospitals and ICUs that use the CereLink ICP Monitor for patient care.
• Neurosurgeons, neurologists, and critical care specialists who depend on accurate ICP readings to make life-saving decisions.
• Patients with traumatic brain injuries, strokes, brain tumors, or other neurological conditions requiring ICP monitoring.

Hospitals have been instructed to stop using the device immediately and return all affected units. However, concerns remain about whether some faulty monitors may still be in use or if alternative monitoring systems are readily available.

What Patients and Families Need to Know

If you or a loved one suffered neurological complications, improper treatment, or unexpected medical deterioration due to the CereLink device, you may have a legal claim.

At KBD, we At KBA Attorneys, we collaborate with top medical professionals, biomedical engineers, and industry experts to:

• Analyze the device failure and determine how it caused harm.
• Investigate manufacturer negligence, including improper testing, design defects, or failure to warn doctors and patients of risks.
• Gather evidence from medical records, FDA reports, and expert testimony to build a strong case.

We have extensive experience in medical device litigation and we are committed to making sure that those harmed by dangerous medical products get the justice they deserve.

Contact us today for a free consultation.