On June17, 2005 Guidant Corporation recalled close to 50,000 heart defibrillators worldwide because of potential malfunctions that could cause injury or death. This recall comes in
wake of two recent deaths among patients who were implanted with Guidant defibrillators. It is believed that Guidant Corporation failed to inform doctors and patients that defibrillators contained a defect that could cause them to short-circuit. The recalled Guidant defibrillators models include: ·Prizm 2 DR, Model 1861, manufactured on or before April 16, 2002 ·Contak Renewal, Model H135, manufactured on or before August 26, 2004 ·Contak Renewal 2, Model H155, manufactured on or before August 26, 2004 ·Prizm AVT Vitality SVT Renewal 3 ·AVT Renewal 4 AVT
On June 24, Guidant issued an advisory concerning these additional defibrillator devices: ·Contak Renewal 3 and 4 ·Renewal 3 and 4 AVT ·Renewal RF
Guidant admits that they discovered defect as early as 2002. However, even though they changed manufacturing of devices, they continued to sell defective defibrillators without notifying doctors or patients of defects.
Although Guidant has conducted this recall, they have not yet advised whether implanted defibrillators should be replaced. The Food and Drug Administration has advised patients to take following steps: 1.Contact your doctor immediately to determine if your defibrillator is a model being recalled by Guidant. 2.Keep your regularly scheduled doctor appointments. 3.Contact your doctor immediately if you experience an electrical shock from your defibrillator. 4.Contact your doctor immediately if you notice a beeping sound coming from your defibrillator.
