FDA Medical Device Recalls (openFDA)
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 number
- Z-0548-2024
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Status
- Open, Classified
- Initiated
- 2023-10-05
- Posted
- 2023-12-14
- Terminated
- not on file
- Reason
- 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
- Device Design
- Action
- 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.
- Quantity
- 4941
- Distribution
- 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.
- Lot, serial or model codes
- UDI-DI 10381780520665 All lots distributed
- 510(k) numbers
- ["K210993","K232890"]
- PMA numbers
- not on file
- Product code
- GWM
- Firm FEI
- 3003418325
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28