FDA Device recall Z-1395-2022
CereLink ICP Monitor
- FDA Device
- Class I
- ongoing
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class I recall of CereLink ICP Monitor by Integra Lifesciences, citing 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 ha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1395-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-06-22 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Reason
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.
Identifiers
| code_info | UDI-DI- 10381780533778; All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1395-2022%22
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