# FDA recall Z-1395-2022

> **Integra LifeSciences Corp.** · Class I · device recall initiated 2022-06-22.

## Product

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

## Reason for recall

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.

## Distribution

Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland, Spain, Sweden, Slovakia, and United Kingdom.

## Key facts

- **Recall number:** Z-1395-2022
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-22
- **Report date:** 2022-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1395-2022

## Citation

> AI Analytics. FDA recall Z-1395-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1395-2022. Source: US FDA. Licensed CC0.

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