Z-0124-2020Class II

Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge...

Name: Z-0124-2020 Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge...
Creator: Integra LifeSciences Corp.
Published: 2019-09-12
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2019-09-12 / Open, Classified

FDA source

Integra LifeSciences Corp. began a recall of Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard... on 2019-09-12. FDA classified it as Class II and gives the reason as "There is a potential for a progressive decline in observed ICP readings of the monitor during use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0124-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-12
Posted: 2019-10-12
Recalling firm: Integra LifeSciences Corporation
Product: Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: There is a potential for a progressive decline in observed ICP readings of the monitor during use.
FDA root cause: Under Investigation by firm
Action: On 9/12/19, the customers were notified by a visit from the Sales Representative who delivered a notification letter at that time. The letter, URGENT: VOLUNTARY MEDICAL DEVICE RECALL, dated 9/12/19, included the following instructions: 1. If you have a CereLink ICP monitor, Model #826820, discontinue using the product as soon as clinically possible and remove the product from service. 2. Your sales representative will facilitate the return of your monitor. 3. Complete the information on the Acknowledgement Form attached to this letter and either provide it to your sales representative or email or fax as indicated on the form. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 781-565-1401
Quantity in commerce: 189
Distribution: The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.
Product codes and lots: All systems

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0124-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0124-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-23	2019-10-12

Product code GWM

K183406Class IICereLink ICP Monitor, CereLink ICP Extension CableIntegra Lifesciences Corp. / cleared 2019-01-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)