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U.S. Department of Health and Human Services

Class 2 Device Recall VITALITY 2 EL

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  Class 2 Device Recall VITALITY 2 EL see related information
Date Initiated by Firm March 23, 2007
Date Posting Updated July 11, 2007
Recall Status1 Terminated 3 on March 02, 2008
Recall Number Z-1055-2007
Recall Event ID 37769
PMA Number P010012 
Product Classification implantable defibrillator - Product Code NIK
Product VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. By using the metallic housing of the pulse generator as an active electrode, combined with the Guidant Endotak two-electrode defibrillation lead, energy is sent via a dual-current pathway from the distal shocking electrode to the proximal electrode and to the pulse generator case. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tacharrhythmias.
Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 551112-5798 USA.
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Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
Manufacturer Reason
for Recall
Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.
FDA Determined
Cause 2
Other
Action An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.
Quantity in Commerce 6,160
Distribution Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.
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.
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