Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

CereLink ICP Monitor Recalled by Integra LifeSciences Corp. Due to Integra has received complaints associated with ICP readings...

Date: June 22, 2022
Company: Integra LifeSciences Corp.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.

Affected Products

CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.

Quantity: 1,210 units

Why Was This Recalled?

Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Integra LifeSciences Corp.

Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report