On July 18, 2005, the following are models of Guidant pacemakers, manufactured
between November 25, 1997 and October 26, 2000, of which some 28,000 remain
implanted in patients worldwide.
Pacemakers of this type are surgically implanted in persons with a heart disease
affecting the heart's ability to generate and conduct electrical impulses. These
devices generate small electrical impulses that trigger the heartbeat.
The reason why they are recalled is because a seal within the devices can leak,
allowing moisture to affect the electronic circuits. This defect can cause the
pacemakers to fail to provide pacing or can cause a rapid heart rate. Other
unexpected device behaviors are also possible. The problems may occur without
warning and can lead to loss of consciousness, and possibly heart failure and
death.
On September 22, 2005, Guidant issued a recall for some of its Insignia and
Nexus implantable pacemakers because of failures, including nine cases requiring
emergency hospitalization. Guidant said that 36 out of 49,500 devices experienced
loss of pacing output, while 16 out of 341,000 devices suffered a telemetry
failure.
The recall expanded in June 2006 when Boston Scientific, which bought Guidant in 2006, announced in the recall of more defibrillators and pacemakers. The
recalled devices include Insignia and Nexus brand pacemakers, Contak Renewal
TR/TR2 cardiac resynchronization pacemakers. On June 23, 2006 Guidant issued
a warning letter to physicians, informing them of the recall expansion and urging
patient exams and possible removal of the defective devices.
If you or someone you love has been injured by A Guidant Pacemaker, defibrillator
or an ICD (implantable cardioverter-defibrillator), please contact us immediately
so we can get you in touch with legal professionals who are experienced with
the Guidant Pacemaker Recall.
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