Z-2053-2009

Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences...

Name: Z-2053-2009 Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences...
Creator: Integra Neuro Sciences
Published: 2009-03-16
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2009-03-16 / Terminated / root cause: manufacturing process

FDA source

Integra Neuro Sciences began a recall of Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring... on 2009-03-16. The reason FDA records is "Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2053-2009
Status: Terminated
Initiated: 2009-03-16
Posted: 2009-09-08
Terminated: 2012-07-19
Recalling firm: Natus Medical Incorporated
Product: Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC. This intracranial pressure (ICP) catheter is indicated for use on patients that require continuous invasive intracranial pressure monitoring and/or cerebrospinal drainage. Access is achieved through a tunneled technique using the included trocar.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: An "Urgent-Product Recall Notification" letter dated March 23, 2009 was issued to consignees. The letter described the issue and instructed customers to examine their inventory immediately to determine whether they have any NL950V - Ventrix Ventricular Tunneling Pressure Monitoring Kits, or NL950VC - Ventrix Ventricular Tunneling Pressure Monitoring Kits with Ventricular Drainage System. Customers were further instructed not to use the above recalled product. Call Integra Customer Service at 1-800-654-2873, and then select 5 for 'Returns and Repairs' to obtain a Returned Material Authorization number, and return the product as directed. Direct questions about the recall to Integra NeuroSciences by calling 1-858-455-1115, extension185.
Quantity in commerce: 274 kits
Distribution: Worldwide Distribution -- US (states of AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, and VA), Belgium and Malaysia.
Product codes and lots: NL950-V - Lot Numbers: 30500R130474 (exp. 8/31/2011); 30500R134098 (exp. 10/31/2011); 30500R139222 (exp. 11/30/2011); 30500R143588 (exp. 1/31/2012); 30500R146383 (exp. 1/31/2012); 30500R147342 (exp. 2/29/2012); and 30500R147899 (exp. 2/29/2012) and NL950-VC - Lot Numbers: 138999 (exp. 9/30/2011); and 142754 (exp. 12/31/2011).

Product code JXG

K904883Class IIOptyxBaxter Healthcare Corp / cleared 1991-07-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)