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.
This recall has been terminated (originally issued September 8, 2009).
- Company
- Integra Neuro Sciences
- Recall Initiated
- March 16, 2009
- Posted
- September 8, 2009
- Terminated
- July 19, 2012
- Recall Number
- Z-2053-2009
- Quantity
- 274 kits
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- US (states of AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, and VA), Belgium and Malaysia.
Lot / Code Info
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).
Root Cause
Process design
Action Taken
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.