Class 2 Device Recall Livewire TC" Ablation Catheter

• Date Initiated by Firm: June 05, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on February 04, 2012
• Recall Number: Z-2313-2008
• Recall Event ID: 48740
• PMA Number: P960016
• Product Classification: Cardiac ablation percutaneous catheter - Product Code LPB
• Product: The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO The St. Jude Medical Livewire TC" Ablation Catheter is a flexible electrode catheter constructed of a radiopaque polyurethane insulation/shaft and incorporated platinum electrode. The distal tip portion may be deflected by a remote control handle located a t the proximal end of t the catheter.
• Code Information: Lot # 2056960
• Recalling Firm/ Manufacturer: St. Jude Medical Cardiovascular Division; 14901 Deveau Pl; Minnetonka MN 55345-2126
• For Additional Information Contact: 952-933-4700
• Manufacturer Reason for Recall: St. Jude Medical has initiated a recall of one lot of Livewire TC" Ablation Catheter. The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated temperatures and formation of coagulum at the tip electrode. If this coagulum were to detach from the product, the worst case this could potentially result in embolization.
• FDA Determined Cause: Labeling mix-ups
• Action: Consignees were sent a "St Jude Medical Urgent Product Recall" letter addressed to "Dear Doctor" and a "Doctor's Acknowledgement Form" . The letter described the product, problem and the possibility of a health hazard. They also requested discontinue of product and gave instructions for return of product. Contact St. Jude Medical at 952-933-4700 if you have questions.
• Quantity in Commerce: 39
• Distribution: Canada and Belgium
• 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