Guidant's Woes Worsen

Originally Published MX July/August 2005

BUSINESS NEWS

In late May, Guidant Corp. (Indianapolis) acknowledged that it had failed to properly inform physicians and patients about a potentially fatal flaw in one of its implantable cardiac defibrillator (ICD) models that resulted in the death of a 21-year-old college student. Since then, new disclosures have continued to worsen Guidant's problems, which now involve a recall of 50,000 ICDs and potentially serious market damage for the company's entire line of cardiac rhythm management products.

In addition to the Ventak Prizm 2 Model 186, which was involved in the widely reported death of the student, the recall has expanded to include the Contak Renewal and Renewal 2, with all three models—approximately 29,000 units—believed to have the potential to malfunction due to short-circuiting. Guidant has offered to replace these devices. The company has also recalled 21,000 Ventak Prizm AVT, Vitality AVT, and Renewal AVT ICDs because of a computer-memory error, which Guidant says can be fixed with noninvasive software reprogramming.