Guidant Notifies FDA of Defibrillator Problems
- Share via
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.
Inside the business of entertainment
The Wide Shot brings you news, analysis and insights on everything from streaming wars to production — and what it all means for the future.
You may occasionally receive promotional content from the Los Angeles Times.
