Recall of the Guidant Defibrillator

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.  (Note: Guidant Corporation was acquired by Boston Scientific in April 2006.)

The devices 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

The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia.  This can lead to a serious, life-threatening event for a patient implanted with these devices.  The FDA received reports of two deaths, which are suspected to be associated with this malfunction.

More recently, in June 2006, Boston Scientific issued another recall on certain defibrillators.  Boston Scientific is recalling:

• 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)

Boston Scientific/Guidant has confirmed five reports of device malfunction among some 27,200 patients worldwide, who have had these devices implanted.  One malfunction occurred at the time of implantation, while, in the other four cases, the patients needed a device replacement.  In two of these cases, the patients lost consciousness when their devices malfunctioned. No deaths have been reported.