Integra LifeSciences Corp. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
All systems
Products Sold
All systems
Integra LifeSciences Corp. is recalling Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible stra due to There is a potential for a progressive decline in observed ICP readings of the monitor during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Recommended Action
Per FDA guidance
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: custsvcnj@integralife.com Outside USA: 781-565-1401
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 noticeDistribution
As reported by FDA
CA, CO, CT, FL, IN, NY, OK, PA, TX, WV, WI
Page updated: Jan 10, 2026