Z-1395-2022Class I

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

Name: Z-1395-2022 CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor
Creator: Integra LifeSciences Corp.
Published: 2022-06-22
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2022-06-22 / Open, Classified / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor on 2022-06-22. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1395-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-06-22
Posted: 2022-07-22
Recalling firm: Integra LifeSciences Corporation
Product: CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Product code: GWM Device, Monitoring, Intracranial Pressure
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.
Root cause tag: design
FDA root cause: Device Design
Action: A recall notification titled 1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION, dated June 22, 2022, was sent by mail. This communicated troubleshooting techniques if an out-of-range reading is encountered when utilizing the Codman CereLink System, while Integra finalized a root cause investigation. A second notification, dated August 23, 2022, for this recall states that Integra is now conducting a removal of Codman CereLink ICP Monitors. Customers are asked to discontinue use of affected devices as soon as possible and remove the devices from service. If an affected device is being used on a patient, continued use should only be determined by an individual risk-benefit analysis by the responsible attending clinician. If the recalled device continues to be used on a patient, the patient needs to be carefully monitored and ensure cable management. If a progressive decline in ICP readings is observed, use another monitoring system for continued patient case as soon as possible. Once patient care is complete, discontinue use of the monitor and remove it from service. As CereLink ICP Monitors are removed from use, a sales representative will facilitate the return of the affected monitor. Complete the Acknowledgement Form and return it to your Account Manager or email it to [email protected] or Fax the form to 1-609-750-4220. Keep a copy of the recall notification for your records. Any questions, contact your Integra Account Manager, Clinical Specialist, or Technical Support at [email protected] or by phone at 888-772-7378.
Quantity in commerce: 1,210 units
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.
Product codes and lots: UDI-DI- 10381780533778; All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1395-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1395-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-22

Product code GWM

K210993Class IICereLink ICP MonitorIntegra Lifesciences Production Corporation / cleared 2021-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)