Integra LifeSciences Corp. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
UDI-DI 10381780520665 All lots distributed
Products Sold
UDI-DI 10381780520665 All lots distributed
Integra LifeSciences Corp. is recalling CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracra due to Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026