Q: What is a defibrillator?
A: A defibrillator is a device surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). These devices deliver an electrical shock to the heart to restore normal heart rhythm.

Guidant Corporation makes defibrillators, which have recently been subject to a recall. In April 2006, Guidant Corporation was acquired by Boston Scientific.

Q: Why were Guidant defibrillators recalled?
A: In June 2005, the U.S. Food and Drug Administration (FDA) issued a nationwide notification of recall of certain Guidant implantable defibrillators and cardiac resynchronization therapy defibrillators. The FDA announced that certain devices are subject to different failures, which could result in their inability to deliver an electrical shock during episodes of arrhythmia.

More recently, in June 2006, Boston Scientific issued another recall on certain defibrillators. Boston Scientific/Guidant has confirmed five reports of device malfunction among some 27,200 patients worldwide who have had these devices implanted.

Q: Which devices are affected by the recalls?
A: The Guidant defibrillators affected by the June 2005 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

In June 2006, Boston Scientific announced a recall on the following defibrillators:

• Some Insignia and Nexus pacemakers
• CONTAK RENEWAL TR and TR 2 cardiac resynchronization pacemakers
• VENTAK PRIZM 2, VITALITY, and VITALITY 2 ICDs (implantable cardioverter defibrillators)