Z-0339-06

NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit

Name: Z-0339-06 NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
Creator: Integra Neuro Sciences
Published: 2005-09-08
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2005-09-08 / Terminated / root cause: labeling and UDI

FDA source

Integra Neuro Sciences began a recall of NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit on 2005-09-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0339-06
Status: Terminated
Initiated: 2005-09-08
Posted: 2006-01-06
Terminated: 2012-03-07
Recalling firm: Natus Medical Incorporated
Product: NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 79
Distribution: Nationwide
Product codes and lots: W050708, W050980, & W050997

Product code GWM

K050720Class IINeurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/system, Models Ns-P, Ns-100Integra Neurosciences / cleared 2005-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)