Recalling Firm / Manufacturer

Boston Scientific CRM Corp

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.

Code Information

Reason of 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.

Date Recall Initiated

March 23, 2007

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. Firm Initiated recall is ongoing.

Contact

Gulf Medical Co.
Riyadh
(01) 4633399

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.