Class 3 Device Recall CONTAK RENEWAL 3 RF & 4 RF

• Date Initiated by Firm: March 11, 2006
• Date Posted: May 16, 2006
• Recall Status: Terminated on December 31, 2006
• Recall Number: Z-0863-06
• Recall Event ID: 34860
• PMA Number: P010012
• Product Classification: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
• Product: CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with suden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. The device also uses accelerometer-based adaptive-rate bradycardia therapy. These CONTAK RENEWAL RF devices feature enhanced telemetry communication with wandless ZIP telemetry. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
• Code Information: Issue affecting devices is a pre-implant issue. Serial number ranges listed below may also include devices not affected (i.e. implanted devices). Model H210 serial number 200031 thru 202462. Model H215 serial numbers 700016 thru 702646. Model H217 serial numbers 700006 thru 702543. Model H219 serial numbers 200021 thru 201747. Model H230 serial numbers 100012 thru 200526. Model H235 serial numbers 100018 thru 650559. Model H239 serial numbers 100018 thru 650272.
• Recalling Firm/ Manufacturer: Guidant Corporation; 4100 Hamline Ave N; Saint Paul MN 55112-5798
• Manufacturer Reason for Recall: Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.
• FDA Determined Cause: Other
• Action: Affected physicians were sent an Urgent Medical Device Safety Information & Corrective Action letter, dated 05/11/06. A press release was issued March 13, 2006 The letter describes the issue and emphasizes the importance of checking battery voltage prior to implant as stated in device labeling. For implanted devices, continue normal follow-up.
• Quantity in Commerce: 8,879
• Distribution: Nationwide, Puerto Rico, Virgin Islands and to countries that include: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iran, Ireland, Israel, Italy, Luxembourg, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom
• 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 and Original Applicant = Boston Scientific Corp.