More Defective Pacemakers Recalled

June 2006

Boston-Scientific got more than they bargained for when they acquired rival heart device manufacturer, Guidant Corp. The company announced a recall of 22,600 cardiac pacemakers and defibrillators due to five reports of malfunctions in patients, including two people who lost consciousness.

Another 27,200 of the devices are already implanted in patients and could also have the same defect. The malfunction could cause the devices to fail or lose power. Boston-Scientific has alerted doctors to the defect and recommended that they schedule appointments with patients to test whether their heart device is working properly. Of the five reported malfunctions, four patients required their devices to be replaced.

The defective Boston-Scientific pacemakers and defibrillators recalled include:

Pacemakers

• Insignia
• Nexus

Cardiac Resynchronization Pacemakers

• Contak Renewal TR
• Contak Renewal TR2

Defibrillators

• Ventak Prizm 2
• Vitality
• Vitality 2

Since early 2005, Guidant has issued warnings or recalled more than 200,000 defibrillators and pacemakers, not including this current recall.

Pacemakers send electrical pulses to the heart, correcting a slow heartbeat. Defibrillators shock the heart into a normal beating pattern when the heart beats too fast.

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