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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Affected units
- 1,210
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
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