—#204305

Product

CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

FDA product code: GWM — Device, Monitoring, Intracranial Pressure
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K210993, K232890
Affected lot / code info: UDI-DI 10381780520665 All lots distributed

Why it was recalled

Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.

Root cause (FDA determination)

Device Design

Action the firm took

On October 5, 2023, the firm issued an updated letter, intended to replace the notification sent on June 22, 2022 for the out-of-range readings issue (RES 90457). As an output of the root cause and failure investigation, the design of the extension cable is being modified to incorporate a solution to address the "out of range readings" issue. The firm instructed customers to return all existing CereLink ICP Extension Cables in their inventory. This includes all CereLink ICP Extension Cables included with the monitor AND all CereLink ICP Extension Cables provided separately. Customers should check their inventory and quarantine any affected product. Once the firm receives the customer's response form, the firm will provide instructions to return the product. Customers with questions about this recall should contact their Account Manager.

Recalling firm

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

Distribution

Distribution pattern: US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL GA IA KY LA MA ME MN ND NE NH NJ NY OK PA RI TN TX UT VA WI WV OUS distribution to Australia/New Zealand, Canada, and Europe/Middle East/Africa.

Timeline

Recall initiated: 2023-10-05
Posted by FDA: 2023-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204305. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.