CereLink ICP Monitor recalled for out-of-range pressure readings
Integra LifeSciences is recalling CereLink ICP Monitors due to electrical interference causing intracranial pressure readings to drift out of range. Affected devices may display an error message indicating sensor or extension cable failure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Class I recalls indicate risk of serious adverse health consequences or death. The rubric requires a minimum score of 4 for Class I recalls. No deaths, injuries, or illnesses are reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling the CereLink ICP Monitor (catalog numbers 826820 and 826820P), an intracranial pressure monitor used in critical care settings. The recall affects approximately 1,210 units distributed worldwide, including locations in the United States, Canada, Australia, and numerous other countries.
The devices may experience electrical interference from components within the monitor's circuit board and from the surrounding environment. This interference can cause intracranial pressure readings to drift to -50 mmHg, which is outside the normal operating range. Affected devices may display an error message stating "sensor or extension cable failure!"
Healthcare providers and patients using this monitor should contact Integra LifeSciences for guidance on appropriate actions. Users should be aware of the potential for out-of-range readings and take appropriate precautions in patient monitoring protocols.
The recalled product
- Product
- CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- sensor-failure
- equipment-malfunction
- electrical-interference
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI- 10381780533778
- All serial numbers.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03