Heart Devices Lead To Manufacturer's Recall, FDA Involved

Guidant Corporation is working with the US Food and Drug Administration to spread the word about a recall that may not be as for consumers to resolve as traditional recalls. At risk are consumers suffering from heart disease who have had cardiac defibrillators implanted in their body. According to the FDA, some of Guidant devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.

The devices affected by this notification are:

• PRIZM 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

The FDA reported that it believed two deaths were linked to malfunctions in these units. The company and government agency are also reviewing data regarding Guidant's PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT units.

For now, the FDA advises taking the following steps:

• If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
• Continue to keep your regular doctor appointments.
• If you feel an electrical shock from your device, immediately contact your doctor.
• If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.

posted by Consumer Help Web Editorial Team at 7:54 AM |