—#194454

Product

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

FDA product code: GWM — Device, Monitoring, Intracranial Pressure
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K210993
Affected lot / code info: UDI-DI- 10381780533778; All serial numbers.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 FCA3@integralife.com 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 technical.support@integralife.com or by phone at 888-772-7378.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

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.

Timeline

Recall initiated: 2022-06-22
Posted by FDA: 2022-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194454. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.