Z-0548-2024Class I

CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial...

Name: Z-0548-2024 CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial...
Creator: Integra LifeSciences Corp.
Published: 2023-10-05
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2023-10-05 / Open, Classified / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable... on 2023-10-05. FDA classified it as Class I and gives the reason as "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...". 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-0548-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-10-05
Posted: 2023-12-14
Recalling firm: Integra LifeSciences Corporation
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.
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.
Product codes and lots: UDI-DI 10381780520665 All lots distributed

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0548-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0548-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-14

Product code GWM

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)