Integra Neuro Sciences INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences
Brand
Integra Neuro Sciences
Lot Codes / Batch Numbers
Lot 100063, all serial numbers
Products Sold
Lot 100063, all serial numbers
Integra Neuro Sciences is recalling INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Moni due to Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifical. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that could result in a maximum Insertion Error of +/- 6mmHg.
Recommended Action
Per FDA guidance
Integra NeuroSciences sent a Recall Notification with a Recall Acknowledgement form to all customers with product currently in their possession through an Integra Field Sales Repesentative on January 28, 2008. The notification advises that the firm has determined that due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg that could result in a maximum Insertion Error of +/- 6mmHg. Customers are asked to examine their inventory immediately to determine if they have any NeuroSensor Model NS-P's lot #100063 on hand and if so to not use the product. Customers are advised to contact their local Integra representative for further assistance. The letter advises that the lot/serial number is located on a white 1/2" x 1/2" label on the large beige optical connector, and can readily be seen through the bottom of the product tray packaging. The letter also advises that this recall pertains to NeuroSensor Model NS-P's, lot # 100063 -all serial numbers. A response form is included. In addition, the Field Sales Representatives have been instructed to physically remove all lot 100063 of NeuroSensor Probes from inventory and provide replacement 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 noticeDistribution
As reported by FDA
CA, GA, NE, NM, NY, TX, WA
Page updated: Jan 10, 2026