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Guidant Defibrillator RecallJune 17, 2005 The following Implantable Cardioverter Defibrillators (ICD's) were recalled by the Guidant Corporation: - Ventak Prizm 2 DR - Model 1861 The devices affected by the July 17, 2005 recall are 29,000 defibrillators. 20,600 of the devices were implanted in the USA. Guidant also informed the FDA that it was to recall the following defibrillators because of "memory errors." - Ventak Prizm AVT - Model 1900 This set of programming flaws caused the recall of 21,000 ICDs, 18,000 of those
were implanted in the USA. Guidant issues a press release notifying the FDA of yet another recall. The most recent recall, devices listed below, implicated 46,000 defibrillators. - Renewal 3 AVT Guidant said it has determined that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion. As of June 2005, Guidant admitted that it was aware of 43 reports of device failures, and two patient deaths. Guidant has acknowledged that the actual rate of failure may be higher than the reported rate and that the number of associated deaths may be underreported, since implantable cardio-defibrillators are not routinely evaluated after death. The FDA and Guidant have advised physicians and patients to make individual decisions about whether to remove and replace the affected defibrillators on the basis of the specific medical situation of the patient. |
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