Class 2 Device Recall

• Date Initiated by Firm: March 10, 2005
• Date Posted: April 13, 2005
• Recall Status: Terminated on July 11, 2005
• Recall Number: Z-0709-05
• Recall Event ID: 31515
• PMA Number: P910023 P030054
• Product Classification: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
• Product: Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343
• Code Information: Too numerous to include here.
• FEI Number: 2017865
• Recalling Firm/ Manufacturer: St Jude Medical; 15900 Valley View Ct; Sylmar CA 91342-3577
• For Additional Information Contact: Nestor Kusnierz; 818-463-2587
• Manufacturer Reason for Recall: Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery.
• FDA Determined Cause: Other
• Action: Notification materials were distributed to sales representatives on March 10, 2005. They will visit each doctor that is following the devices.
• Quantity in Commerce: 1488
• Distribution: Nationwide, Canada, Australia, Sweden, Brazil, Colombia, Argentina.
• 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 = NIK