Class 2 Device Recall VITALITY DR ICD

• Date Initiated by Firm: January 07, 2008
• Date Posted: August 21, 2008
• Recall Status: Terminated on December 30, 2008
• Recall Number: Z-1513-2008
• Recall Event ID: 46297
• PMA Number: P960040
• Product Classification: Defibrillator - Product Code LWP
• Product: VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Code Information: Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Boston Scientific CRM.
• Recalling Firm/ Manufacturer: Boston Scientific CRM Corp; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• For Additional Information Contact: 651-582-4000
• Manufacturer Reason for Recall: Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. This update identifies additional VITALITY ICD
• FDA Determined Cause: Device Design
• Action: An Urgent Medical Device Information Update to May 2006 Product Advisory, dated January 04, 2008, was sent to implanting physicians and physicians following implanted devices beginning Monday, January 07, 2008. The letter described a malfunction that can occur when the ICD is implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. The physicians were asked to review records to determine if an affected device was implanted subpectorally. An AP radiograph should be done to determine specific device orientation for subpectoral implants. If a subpectoral implant is in a susceptible orientation, consider repositioning or replacement for physically active patients who regularly need device therapy. Follow patients with susceptible devices at 3-month intervals.
• Quantity in Commerce: BSC CRM estimates that the number of devices implanted in a susceptible orientation is likely less than 1% of the total active implants 25,000 (w.w.)
• Distribution: Nationwide and Worldwide: Bolivia, Panama, Iran, Saudi Arabia, Kuwait, United Arab Rep., Austria, Belgium, Cyrus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, India, Australia, New Zealand, Malaysia, Singapore, Hong Kong, China, Israel, Turkey, Thailand, and Canada.
• 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