FDA Medical Device Recalls (openFDA)
Integra Neuro Sciences: NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
- Recall number
- Z-0339-06
- Recalling firm
- Integra Neuro Sciences
- Product
- NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
- Status
- Terminated
- Initiated
- 2005-09-08
- Posted
- 2006-01-06
- Terminated
- 2012-03-07
- Reason
- 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
- 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
- 79
- Distribution
- Nationwide
- Lot, serial or model codes
- W050708, W050980, & W050997
- 510(k) numbers
- ["K050720"]
- PMA numbers
- not on file
- Product code
- GWM
- Firm FEI
- 2023988
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28