Guidant Corporation Implantable Cardiac Defibrillators

The Food and Drug Administration (FDA) approved the first cardiac implantable defibrillator (ICD) over 10 years ago. ICDs are designed to shock a heart with an abnormal beat back to a normal rhythm, but defects have caused some devices to malfunction, leading to injuries and even deaths.

Guidant Corporation, located right in our backyard in St. Paul, Minnesota, is a leader in ICD development and production. In February, 2005, Guidant submitted a report to the FDA disclosing the fact that its Ventak Prism 2DR ICD was short-circuiting at a rate of about one device per month. The next month, the first victim of Guidant's ICD malfunctioning, a 21-year-old college student from Minnesota, collapsed and died while on a bicycling trip. Guidant finally admitted flaws in its ICDs to the public on May 23, 2005, one day before a story disclosing the truth was to be published in the New York Times.

On June 16, 2005, the FDA announced a recall of 50,000 Guidant ICDs, including these models: Prism 2 DR Model 1861, manufactured on or before April 16, 2002; Contak Renewal, Model H135, manufactured on or before August 26, 2004; Contak Renewal 2, Model H155, manufactured on or before August 26, 2004; Prizm AVT; Vitality AVT; Renewal 3 AVT; and Renewal 4 AVT. On June 24, 2005, the FDA also issued an advisory for the following Guidant ICD models: Contak Renewal 3 & 4 and Renewal RF.

On July 18, 2005, the FDA announced a second recall of Guidant ICDs manufactured between November 25, 1997 and October 26, 2000, including these models: Pulsar Max; Pulsar; Discovery; Meridian; Pulsar Max II; Discovery II; Virtus Plus II; Intelis II; and Contak TR. As of that date, Guidant had identified sixty-nine (69) devices that may have failed of the 28,000 devices implanted world-wide. Contact the attorneys at Goldenberg & Johnson to find out whether your device's specific serial number has been recalled.

On June 26, 2006, Guidant and the FDA announced that Guidant's ICD models Ventak Prism 2, Vitality, and Vitality 2 have been associated with five reports of device malfunctions. Patients with these ICDs may experience inappropriate sensing or premature battery depletion.

Guidant admits that it knew of the defects in the ICDs in 2002 and changed its manufacturing to fix the problem. Guidant chose to conceal this information from doctors and patients and continued to sell the remaining defective stock regardless of the fact that improved ICDs were available. Unfortunately, Guidant made a business decision to conceal this information to protect its profits over its thousands of patients.

If you or a loved one has been affecting by a Guidant ICD, the attorneys at Goldenberg & Johnson can answer any questions and discuss your potential case. You can speak to one of our attorneys by calling us toll free at (800) 279-6386.