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RECENT CASES |
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GENERAL INFORMATION |
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Guidant Defibrillator and Pacemaker Recall Timeline |
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following is a summary of key events in
the Guidant device recalls and warnings. |
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- May 23, 2005 - Guidant Issues Safety
Advisory Concerning Defibrillator
Guidant issues a safety advisory about certain models of its heart defibrillator,
reportedly after the company learned an article by the New York Times
was being prepared claiming that Guidant did not tell doctors or patients
for three years that the device contains a flaw.
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- June 1, 2005 - Lieff Cabraser Files
Lawsuit Against Guidant
Lieff Cabraser files a lawsuit against Guidant Corporation in federal
court in Indianapolis, Indiana, on behalf of a proposed nationwide class
of patients implanted with the Guidant Ventak Prizm defibrillator. This
was the first lawsuit filed against Guidant based on its faulty defibrillator.
The complaint alleges that Guidant misrepresented the safety of its defibrillator,
which is subject to short circuiting and malfunctioning.
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- June
17, 2005 - Guidant Announces Recall of
Nearly 50,000 Defibrillators
Guidant announces recall of cardiac defibrillator devices. Advisory
states that a magnetic switch in these devices may get stuck in the
closed position, which in some cases inhibits their ability to treat
ventricular or atrial tachyarrhythmias and can accelerate battery depletion.
The recall includes the Ventak Prizm 2 DR (model 1861), Contak Renewal
(model H135) and Contak Renewal 2 (model H155).
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- June
24, 2005 - Guidant Expands Defibrillator
Recall
Guidant announces an additional 46,000 defibrillator devices are potentially
defective. Advisory includes all serial numbers of its Contak Renewal
3 and 4, Renewal 3 and 4 AVT, and Renewal RF defibrillator devices.
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- July
1, 2005 - FDA Classifies Defibrillator
Recall as Class I
FDA classifies the recall of certain Guidant defibrillator models as
a Class I recall, the most serious level of product recall. The models
given Class I status include: Ventak Prizm 2 DR (model 1861), Contak
Renewal (model H135) and Contak Renewal 2 (model H155.) The models
given Class II status, meaning that any injury caused by a malfunction
should be temporary or reversible, include: Ventak Prizm AVT, Vitality
AVT, Renewal AVT, Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal
RF.
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- July
18, 2005 - Guidant Alerts Physicians
to Potential Flaw in Pacemakers
Guidant issues safety advisory for the Pulsar Max, Pulsar, Discovery,
Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and
Contak TR pacemaker devices, alerting physicians and patients that
the sealing component in the pacemakers can degrade, resulting in higher-than-normal
moisture in the devices and possible malfunction.
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- July
22, 2005 - Guidant Updates Original Recommendations
to Physicians
Guidant announces that a software fix for recalled defibrillators it
had recommended on June 17, 2005, to prevent possible device failure
did not appear to solve the problem and can significantly increase
the risk to patients
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- September
22, 2005 - Guidant Recalls some Insignia
and Nexus Pacemakers
Guidant issues
a recall for some of its Insignia and Nexus
implantable pacemakers because of failures,
including nine cases requiring emergency
hospitalization. Guidant said that as of
September 6, 36 out of 49,500 devices experienced
loss of pacing output, while 16 out of
341,000 devices suffered a telemetry failures.
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| Copyright © 2010 Lieff Cabraser Heimann & Bernstein, LLP |
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