The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Integra LifeSciences has issued a letter to affected customers recommending certain Codman Microsensor Basic Kits and Cerelink ICP Sensor Basic Kits be removed from where they are used or sold. Affected devices:
What to Do
Identify affected lots and remove them immediately from service or further distribution.
On December 12, Integra LifeSciences sent all affected customers a letter recommending the following actions:
For Customers:
- To identify the impacted part number and lot number:
- Check your product labels – see Figures below for Product Labels and where to locate the part number and lot number on the labels. The lot number will be 7 digits long and includes only numbers and no letters.
- Review the full list of affected lots to confirm if your part number and lot number are affected.
- If you do have affected units, remove them immediately from service and quarantine them.
- Forward this notice to those who utilize the product so they are aware of this recall and can identify and quarantine any affected product that may remain in clinical areas.
- If you have affected product, Customer Service will contact you upon receipt of your acknowledgement form and provide a Return Material Authorization (RMA) number and directions to return the affected product. For returned product, you may request a credit for the same or alternative sensors based on available inventory.
For Distributors:
- To identify the impacted part number and lot number:
- Check your product labels – see Figures below for Product Labels and where to locate the part number and lot number on the labels. The lot number will be 7 digits long and includes only numbers and no letters.
- Review the full list of affected lots to confirm if your part number and lot number are affected.
- If you do have affected product, remove the product from further distribution.
- If you have expired products, please ensure that you discard them per your facility’s policies and procedures and that you do not use them.
- Please check your customer traceability records for shipments of affected catalog and lot numbers.
- Please create an acknowledgement form from you to your customers. If your customers contact us, we will not be able to directly assist them. We will direct them back to you.
- Forward a copy of the Field Safety Notice to any of your customers that have purchased the attached catalog and lot number.
- When the form from you has been received and it is noted that you have the affected product, Customer Service will contact you and provide an RMA number and directions to return the product. Distributors can request a credit for the quantities which they return.
- SALES REPS: When the form from you has been received and it is noted that you have the affected product, Customer Service will provide you with directions to return the product.
Figure 1: Product Label for CODMAN MICROSENSOR Basic Kit (Part# 626631US).
Figure 2: Product Label for CERELINK ICP SENSOR Basic Kit (Part# 826850)
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Integra LifeSciences stated that certain lots of Microsensor and Cerelink ICP Kits were released with potential corrosion stains on the surface of the included 14-gauge Tuohy Needle.
Use of affected product with potential corrosion on the 14-gauge Tuohy Needle (found in the kit) may lead to inflammation, requiring professional medical intervention beyond the standard of care, toxic response, infection, and fever. If the product has already been used, there is no long-term risk to the patient, and no follow-up is required besides standard operative care.
As of December 12, 2025, Integra LifeSciences has reported one serious injury and no deaths associated with this issue.
Device Use
The Codman Microsensor Basic Kit and Codman Cerelink ICP Sensor Basic Kit are used for direct intracranial pressure monitoring. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Integra LifeSciences at custsvcnj@integralife.com or 1-800-654-2873.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
