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RECENT CASES |
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GENERAL INFORMATION |
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Guidant Defibrillator, Pacemaker and Ancure Stent-Graft
Recall Timeline |
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following is a summary of key events in
the Guidant device recalls and warnings. |
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- March
2001 - Ancure Device Pulled from
Market
Endovascular Technologies, a subsidiary of Guidant, withdraws the Ancure
endograft device from the market. Endovascular Technologies admits that
it had failed to submit 2,628 incidents of device malfunctions
and injuries to patients during surgery to insert it out
of a total of 7,632 medical devices sold. Among the unreported incidents
were 12 deaths and 57 emergency operations performed when the device's
delivery system became stuck in the patient's body.
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- June
12, 2003 - Charges Filed Against
Guidant Subsidiary Concerning Ancure
Device
Federal prosecutors charge Endovascular Technologies with 10 felony counts,
including false statements to the Food and Drug Administration (FDA)
in connection with the Ancure device. The complaint filed alleges that
the Ancure device often malfunctioned and Guidant asked doctors to use
it in waays not approved by the government. Endovascular Technologies
pleads guilty to the charges.
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- June 16, 2003 - Guidant Announces
It Will Stop Making Ancure Endograft
System
Nearly two years after reintroducing the Ancure device in August 2001
with FDA-approved modifications in the device's warnings to customers
and instructions to doctors, Guidant announces that it would stop making
the Ancure Endograft System.
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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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Our Guidant defect
lawyers have years of experience successfully
representing patients with faulty or
defective medical implants. |
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There is no
charge or obligation
for our review of your case. |
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We are pleased
to visit Guidant patients, or families
of loved ones who died, at or near
where you live and at no cost, to discuss
your legal rights and answer your questions. |
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To assist our
clients with their claims, we have
on staff nurses with cardiac training
and have retained physicians to provide
expert advice. |
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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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represents clients in a wide range of cases, including personal
injury and wrongful
death lawsuits. Our personal injury attorneys
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and support possible for our clients. This website provides information
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defects and related lawsuits. |
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About Lieff Cabraser: We have
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residents of Alaska, Alabama, Arkansas, Arizona, California,
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Among the cases our personal injury
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rollover accidents, popcorn
workers lung injuries, and Ford
switch fires.
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| Copyright © 2008 Lieff Cabraser Heimann & Bernstein, LLP |
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