Integra LifeSciences Corp.: Medical Device Recall in 2022 - (Recall #: Z-1395-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.

Product Classification:

Class I

Date Initiated: June 22, 2022

Date Posted: August 3, 2022

Recall Number: Z-1395-2022

Event ID: 90457

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.

Status: Ongoing

Product Quantity: 1,210 units

Code Information:

UDI-DI- 10381780533778; All serial numbers.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated