Boston Scientific Recalls Guidant Heart Devices

By Amy Teeple

Published on June 26, 2006

The current recall initiated by Boston Scientific is for Guidant-acquired products including the Contak Renewal TR/TR2 cardiac resynchronization pacemakers, the Nexus and Insignia brand pacemakers, and Ventak Prizm 2, Vitality, and Vitality 2 implantable cardioverter defibrillators (ICDs). The models are being recalled because an electrical flaw may cause the devices to fail.

The pacemakers and ICDs may have faulty low-voltage capacitors, which store electrical charges. This defect may cause the heart device to fail, causing potentially deadly outcomes.

Boston Scientific is requesting that its sales force and hospitals who already have the defective devices in stock return the products. However, about 27,000 of the devices with the potential defect have already been surgically implanted in patients. The company is recommending that patients with the implanted devices see their doctor as soon as possible.

Since mid-2005, over 88,000 Guidant defibrillators and about 200,000 of the medical device maker's pacemakers have either been recalled or have had safety warnings issued. This newest recall of heart devices has caused Boston Scientific stock to drop to its lowest point in almost four years.

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