May 16, 2006
Boston Scientific Corp. said it has warned physicians that another 996 defibrillators made by its Guidant unit may quit prematurely, leaving heart failure patients unprotected from sudden cardiac death.
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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.
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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April 12, 2006
Scheduled to start this week, the first Guidant defibrillator lawsuit trial was delayed due to problems scheduling a witness. The Texas trial is expected to now start in July, according to Judge Jack Hunter.
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April 05, 2006
The San Jose Mercury News reports that Guidant's rival Medtronic is suing the medical device maker claiming Guidant is infringing on its patents. The devices in question are two of Guidant's heart stents - the Multi-Link Vision and Xience V. Stents are used to prop open arteries after they have been clogged. The Vision stent is an older model made of bare metal, while the Xience is a drug-coated stent which is designed to prevent arteries from re-clogging. Stent technology is moving away from bare-metal and advancing toward drug coating.
April 04, 2006
Guidant announced last week that it had stopped enrolling patients in Japanese clinical trials and halted shipments to Europe for their Xience heart stents after discovering some of the stents didn't meet quaity sandards.
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