The U.S. Food and Drug Administration (FDA) issued an early alert regarding safety concerns with specific lots of Integra LifeSciences devices, highlighting potential risks for healthcare professionals and distributors. This communication addresses serious quality issues affecting Intracranial Pressure (ICP) monitoring convenience kits, emphasizing the need for immediate action to mitigate risks.
Which products are affected?
The FDA has identified two specific kits from Integra LifeSciences that are impacted:
- CODMAN MICROSENSOR Basic Kit: Model Number 626631US, UDI-DI 10381780514473
- CERELINK ICP SENSOR Basic Kit: Model Number 826850, UDI-DI 10381780520672
Both kits feature a 14-gauge Tuohy Needle, known for potential corrosion stains. The corrosion defect creates risks including local inflammation, toxic response, fever, and infection that require urgent professional medical intervention.
What is Integra LifeSciences recommending?
On December 12, 2025, Integra LifeSciences issued a safety letter for customers to take these actions:
- Identify affected lots using product labels and remove them from service/distribution immediately.
- Quarantine affected products and notify stakeholders within clinical environments.
- Prepare an acknowledgment form to facilitate product returns.
- Coordinate returns directly with Integra LifeSciences to receive a Return Material Authorization (RMA) number.
Distributors were advised to share the Field Safety Notice with downstream customers and confirm the removal, quarantine, and subsequent return of affected products. Credit can be requested for returned units.
What safety risks exist?
The affected kits are vital for intracranial pressure monitoring in subdural and intraparenchymal applications. Despite their critical purpose, the noted corrosion on needles can lead to patient complications.
As of December 12, 2025, one serious injury was reported due to the issue, but no deaths have been attributed to the faulty devices. The manufacturer confirms there is no risk of long-term harm for patients who were treated using these products beyond standard operative care.
How can you report adverse events or quality concerns?
Healthcare professionals and consumers are encouraged to report quality problems or adverse reactions to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. The manufacturer can also be contacted directly at custsvcnj@integralife.com or by calling 1-800-654-2873.
Conclusion
The FDA emphasizes vigilance and swift action to address concerns raised by Integra LifeSciences regarding their ICP monitoring kits. Clinical and quality teams should ensure compliance with recommended withdrawal procedures while maintaining traceability and clear communication with stakeholders.
Disclaimer
This post is informational in nature and intended for professionals within clinical, regulatory, or quality fields. It does not constitute legal advice or substitute for direct regulatory consultation.