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U.S. Department of Health and Human Services

Class 2 Device Recall Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit

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  Class 2 Device Recall Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit see related information
Date Initiated by Firm March 16, 2009
Date Posted September 08, 2009
Recall Status1 Terminated 3 on July 19, 2012
Recall Number Z-2053-2009
Recall Event ID 51674
510(K)Number K904883  
Product Classification Shunt, central nervous system and components - Product Code JXG
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.
Code Information 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).
Recalling Firm/
Manufacturer		 Integra Neuro Sciences
5955 Pacific Center Blvd
San Diego CA 92121
For Additional Information Contact
858-455-1115
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JXG and Original Applicant = BAXTER HEALTHCARE CORP.
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