Guidant e-Resource

Class I FDA recall

April 17, 2006

The FDA has classified Guidant's action as a Class I recall. Recall classifications can fall into one of three categories, with Class I being the most serious. These numerical classifications are based on the probability that the device failure could lead to adverse health effects. In a Class I recall, there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.

Misdiagnosis Leads to Guidant Pacemaker Implant

April 14, 2006

The Racine Journal Times tells the story of Ron Bell, who was driving to work when his heart stopped and he passed out. Somehow he recovered to drive himself to the hospital, where a Guidant pacemaker was implanted. The device had to be replaced after five years.

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