Boston Scientific/Guidant and the Food and Drug Administration (FDA) is warning
all cardiac healthcare professionals, risk managers and patients that approximately
73,000 Implantable Cardiac Defibrillators (ICD) and Cardiac Resynchronization
Therapy Defibrillators (CRT-Ds) were recalled worldwide due to a malfunction
with the defibrillator’s capacitor.
The recall includes a combination of devices within the CONTAK RENEWAL® 3 & 4, VITALITY and VITALITY 2 families. This recall is similar to the recall in May 2006,
but the failure modes and patient reactions are very different.
What are implantable cardiac defibrillators (ICD)?
An ICD is a small electronic device that is inserted in your chest to help prevent sudden
death from cardiac arrest by monitoring your heart rhythm. If your heart begins to beat
abnormally fast, the ICD will activate and deliver an electrical shock to terminate the
abnormal rhythm.
What is wrong with the capacitors?
The devices that are affected will cause the capacitor to malfunction that could lead to premature
battery depletion. This will ultimately cause the elective replacement indicator (ERI) and the
end of life (EOL) to less than three months.
ICD & CRT-Ds distributed to the US & are being recalled:
- Contak Renewal 3 HE CRT-Ds – (Models H177 and H179)
- Contak Renewal 3 CRT-Ds – (Models H170 and H175)
- Vitality 2 DR ICDs (T165)
- Vitality 2 VR ICDs (T175)
- Vitality AVT ICDs (A155)
- Vitality DS DR ICDs (T125)
- Vitality EL DR ICDs (T135)
George Sink Injury Lawyers, P.A., 7011 Rivers Ave., North Charleston, SC works in association with the Fox Law Firm, PC on Guidant cases. The claims will be handled by Fox lawyers who principally practice in offices located at 4514 Cole Ave., Dallas, TX working in association with George Sink, P.A. Injury Lawyers.
