Integra Neuro Sciences NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
Brand
Integra Neuro Sciences
Lot Codes / Batch Numbers
W050708, W050980, & W050997
Products Sold
W050708, W050980, & W050997
Integra Neuro Sciences is recalling NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit due to Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of 2 mmHg maximum ICP drift within the first 24 hours of monitoring.
Recommended Action
Per FDA guidance
Notify Customers and Sales Representatives who received the product by letter sent via Federal Express. Customers will be instructed that an Integra Sales Representative will contact them to arrange for return of affected product.
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 noticePage updated: Jan 10, 2026