Class 2 Device Recall Guidant VITALITY AVT ICD

• Date Initiated by Firm: June 17, 2005
• Date Posted: June 30, 2005
• Recall Status: Terminated on March 02, 2008
• Recall Number: Z-0955-05
• Recall Event ID: 32391
• PMA Number: P960040/S29 P960040S035
• Product Classification: Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
• Product: VITALITY AVT, model A135 and model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
• Code Information: all serial numbers
• Recalling Firm/ Manufacturer: Boston Scientific CRM Corp; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• For Additional Information Contact: 866-484-3268
• Manufacturer Reason for Recall: The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.
• FDA Determined Cause: Other
• Action: Firm issued a Dr. Doctor letter dated 06/17/05. Letter informs physicians of the issue, clinical implications, recommendations and action taken by the firm.
• Quantity in Commerce: 22,575 devices (19,446 implanted world wide)
• Distribution: worldwide. To the US and OUS countries to include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and 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 = LWP