Class 2 Device Recall RENEWAL 3 DS HE ICD

• Date Initiated by Firm: June 16, 2005
• Date Posted: August 03, 2005
• Recall Status: Terminated on November 17, 2005
• Recall Number: Z-1065-05
• Recall Event ID: 32495
• PMA Number: P010012S008
• Product Classification: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
• Product: CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. Provides ventricular tachyarrhythmia and cardiac resynchronization therapies.
• Code Information: 508822, 508827 and 508862
• Recalling Firm/ Manufacturer: Guidant Corporation; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• Manufacturer Reason for Recall: Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.
• FDA Determined Cause: Other
• Action: Sales Representatives notified 06/16/05 to return devices in their area.
• Quantity in Commerce: 3
• Distribution: CA, IL, MI, MO, OR and PA
• 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