Recent Guidant News
Guidant: 28,000 pacemakers may need to be replaced July 18, 2005 at 3:58 PM
Guidant Corp. said Monday it has advised doctors that about 28,000 of its older-generation pacemakers may malfunction and need to be replaced in some patients. The Indianapolis-based company, already beset with a series of recent recalls of heart defibrillators, said the pacemakers affected by the latest announcement have not been sold or implanted for the last four years.
Heart Device Sold Despite Flaw, Data ShowsBy Barry Meier
June 2, 2005 - When the Guidant Corporation told doctors last week that a popular implantable heart defibrillator had failed in a small number of cases because of an electrical flaw, it also said that it had fixed the flaw in devices produced after mid-2002.
But now data provided by Guidant to a Minnesota hospital suggests that the company continued to sell the potentially flawed devices for months after it changed the way it made the device and had begun selling the new ones.
Guidant Didn't Disclose a Flaw in Defibrillator for 3 YearsBy Barry Meier
May 24, 2005 - A medical device maker, the Guidant Corporation, did not tell doctors or patients for three years that a unit implanted in an estimated 24,000 people that is designed to shock a faltering heart contains a flaw that has caused a small number of those units to short-circuit and malfunction.
Guidant Corp. failed to inform doctors or patients for three years that one of its defibrillators, the Ventak Prizm 2 Model 1861, implanted in an estimated 24,000 patients had a defect that caused some of the devices to short-circuit and malfunction.
The defect came to light after the sudden death in March of a 21-year-old college student with heart disease who had the Guidant defibrillator implanted in his chest, the report said. Guidant, which is being acquired by Johnson & Johnson, acknowledged that Joshua Oukrop's defibrillator had short-circuited.
Following Oukrop's death, Guidant told his doctors that it was aware of 25 other cases in which the defibrillator had been affected by the same flaw. Guidant executive, Dr. Joseph Smith, as saying the medical device maker had not seen a compelling reason to issue an alert to physicians because the unit's failure rate was very low and replacing the devices might pose greater patient risks.
