CereLink ICP Monitor — Class I medical device recall Z-1395-2022
Ongoing recall by Integra LifeSciences Corp., reported 2022-08-03, distributed nationwide. Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manif
| Recall number | Z-1395-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2022-06-22 |
| Classified | 2022-07-22 |
| Reported by FDA | 2022-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, IE, IL, IT, LT, LV, NL, NO, NZ, PK, PT, SA, SE, SK, ZA |
| Quantity | 1,210 units |
| Model numbers | 826820, 826820P |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1395-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.