Recalling Firm / Manufacturer

Boston Scientific CRM Corp

Product

VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), 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. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tachyarrhythmias. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. Devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing).

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.