On December 14, 2005 Guidant announced that 3 more patients with recalled defibrillators made by Guidant have died, bringing the total number of known deaths linked to the faulty products to seven. Guidant is under investigation by federal and state officials and faces dozens of lawsuits over its recalls. Guidant Corp. on October 14, 2005 told U.S. regulators that they received reports of 6 additional failures of implantable heart defibrillators since issuing a July notice about the devices used to regulate cardiac rhythms.
The failures were in the Contak Renewal and Renewal 2 models, the FDA said in an update posted 10/13/05 on the agency’s website. The two devices were among models included in warnings Guidant sent to doctors in June, which the FDA classified July 1 as recalls. The new reports of failures bring the total worldwide to 21, including three cases in which patients died, Daniel Schultz, the director of the FDA’s Center for Devices and Radiological Health, said.
Guidant Corp. has recalled several models of its cardiac defibrillators due to defects in the devices and numerous reports of device failure and death. The defibrillator recall and its follow-up advisory combined affect approximately 74,900 devices worldwide. The implantable cardioverter defibrillators, or ICDs, are intended to sense irregular heart rhythms and to send an electrical pulse to the heart to shock it into beating properly. The Guidant defibrillator defects include short circuiting, problems with the magnetic switch and computer memory problems. The defect that causes short circuiting of the device has caused two deaths to date, including the sudden death in March 2005 of a 21-year-old college student. Following are details of the models affected by the recall and the follow-up advisory:
June 16, 2005 – Guidant recalled 50,000 defibrillator devices including
the following models:
Prizm 2 DR, Model 1861, manufactured on or before April 16, 2002
Contak Renewal, Model H135, manufactured on or before Aug. 26, 2004
Contak Renewal 2, Model H155, manufactured on or before Aug. 26, 2004
Prizm AVT Vitality
Renewal 3 AVT
Renewal 4 AVT
June 24, 2005 – Guidant issued an advisory about additional defibrillator devices including the following models:
Contak Renewal 3 and 4
Guidant claims that it discovered the short circuiting defect in 2002 and changed the manufacturing of the devices that year to correct the defect. However, Guidant continued to sell the old defective devices without notifying doctors that improved ones were available. Defibrillators cost approximately $25,000 apiece. Guidant’s 2004 defibrillator sales totaled $1.8 billion, signaling that until recently, Guidant may have been more motivated by profits than by patient safety.
Heart patients with a defibrillator who are unsure if their device is one of the malfunctioning models should contact their doctor as soon as possible to determine if their model requires replacement, if their device can be reprogrammed, or if their device is not affected by the recently announced safety issues.
On June 26, 2005, the FDA and Guidant informed all patients and medical professionals that Guidant’s Ventak Prizm 2, Vitality and Vitality 2 Implantable Cardioverter Defibrillators have been associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Patients who have these particular ICD devices may experience inappropriate sensing or early battery depletion.