Class 2 Device Recall Supreme Electrophysiology Extension Cable

• Date Initiated by Firm: June 01, 2011
• Date Posted: August 05, 2011
• Recall Status: Terminated on August 16, 2012
• Recall Number: Z-2955-2011
• Recall Event ID: 59392
• Product Classification: Cable, electrode - Product Code IKD
• Product: Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55345. Supreme Electrophysiology Extension Cable used to connect Electrophysiology catheters to external diagnostic or therapeutic equipment. The section indexing connector located a t the distal end of the cable will only connect to SMJ Electrophysiology catheters.
• Code Information: Batch # 3334664
• FEI Number: 2182269
• Recalling Firm/ Manufacturer: St. Jude Medical; 14901 DeVeau Place; Minnetonka MN 55345
• For Additional Information Contact: 952-933-4700
• Manufacturer Reason for Recall: St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. Jude Medical has determined that the incorrectly labeled product poses no safety risk since the extension cable can be safely used with a corresponding Quadripolar catheter but cannot be incorrectly connected to a Hexapolar catheter.
• FDA Determined Cause: Labeling mix-ups
• Action: St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE FIELD ADVISORY NOTICE" letter dated June 8, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate the affected product and to complete and return an attached SJM AFD Reconciliation Form. The form will be used to replace product and as documentation that the customers received the notice. Fax the completed form to 877-497-031. Contact the Director of Product Marketing at 512-329-1054 for questions regarding this notice.
• Quantity in Commerce: 32
• Distribution: Nationwide Distribution-USA (nationwide) including the states of FL, NC, NY, and OR.
• 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.