Class 2 Device Recall Biosense NaviStar RMT Catheters

• Date Initiated by Firm: October 02, 2008
• Date Posted: November 19, 2009
• Recall Status: Terminated on November 23, 2009
• Recall Number: Z-0369-2010
• Recall Event ID: 50784
• PMA Number: P990025
• Product Classification: radiofrequency ablation catheter, electrode recording catheter - Product Code LPB
• Product: Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02
• Code Information: All lot numbers
• Recalling Firm/ Manufacturer: BioSense Webster, Inc.; Circuito Interior Norte, #1820; Parque Industrial Salvarcar; Cd. Juarez, Chihuahua Mexico
• For Additional Information Contact: 800-729-9010
• Manufacturer Reason for Recall: Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. Therefore the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to u
• FDA Determined Cause: Process control
• Action: The firm sent an "Urgent Medical Device Correction" letter to consignees on October 6, 2008 informing consignees. Users were advised to pay "close attention to the location of the ablation catheter icon on the map viewer when applying RF energy." If consignees suspect that they have a defective NAVISTAR RMT Catheter, they were instructed to notify Biosense Webster and to return the defective catheter for evaluation and refund/replacement. Customer were instructed to contact their local Biosense Webster representative for any questions or further information. No return reply was requested.
• Quantity in Commerce: 2180 Units
• Distribution: CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI
• 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.

• PMA Database: PMAs with Product Code = LPB