Guidant Notifies FDA of Defibrillator Problems
From Reuters
Guidant Corp. said it had notified regulators about problems with its defibrillators and said it was working with the Food and Drug Administration.
Guidant, in a letter to doctors dated May 23, said a line of its implantable defibrillators contained a flaw that had caused a small number of them to malfunction, but it did not recommend the products be replaced.
Guidant said the clinical performance of its device, the Ventak Prizm 2 DR ICD, “continues to exceed design expectations.”
On Tuesday, the New York Times reported the death in March of a 21-year-old who used a Guidant defibrillator.
