FDA recall Z-1395-2022

Integra LifeSciences Corp. · Class I · device

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

Status
Ongoing
Initiation date
2022-06-22
Report date
2022-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

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