LANCASTER
OFFICE: 2148 Embassy Dr.
Suite 107
Lancaster, PA 17603
Tel: (717) 431-4000
Fax: (717) 233-3029
CARLISLE OFFICE:
26 State Avenue
Suite 103
Carlisle, PA 17013
Tel: (717) 241-2244
Fax: (717) 233-3029
HANOVER OFFICE:
217 Frederick St.
Hanover, PA 17331
Tel: (717) 630-8200
Fax: (717) 233-3029
YORK OFFICE:
2550 Kingston Rd.
Suite 220
York, PA 17402
Tel: (717) 845-7800
Fax: (717) 233-3029
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 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.
Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators
recalled:
The following ICDs and CRT-Ds were distributed in the United States and 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)
These devices have been removed from
distribution and are being retrieved from
hospital inventory.
If you have
any of the Guidant Heart Defibrillators
listed above installed, contact the Law Offices of Handler, Henning & Rosenberg, LLP at 1-800-422-22244 to discuss your case.
