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 FDA Issues Nationwide Notification of Recall of Certain Guidant
Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators
On Friday, June 17th, 2005, Guidant Corporation announced a recall of
the following medical devices / implantable cardiac
defibrilators (ICDs):
- 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
There are approximately 50,000 patients in the
United States with one of these recalled defibrillators. Guidant Corp. has said
that the devices have malfunctioned at least 45 times, causing two deaths.
Recalls linked to ICD's are not uncommon, and with
heart disease still the number one cause of death in the United States, the
safety of these medical devices is of great concern.
These surgically implanted defibrillators can develop an internal short circuit
without warning, resulting in failure to deliver a shock when needed. The
devices are implanted under the collarbone and wired to the heart of patients
suffering from life-threatening heart arrhythmia (abnormal rhythm). When
functioning properly the units can detect when the heart is beating out of
rhythm, and deliver a series of electrical shocks to correct the arrhythmia.
The recall is linked to a potential flaw where some
could short circuit and not work at all. So, at the very moment when the
patient's life depends on the reliability of the ICD, the device can
malfunction.
The MEDLaw Legal Team of Janet, Jenner & Suggs is representing patients
and families who have been harmed by the malfunctioning of Guidant
defibrillators. We are a nationally recognized law firm dedicated to
representing victims of negligently manufactured medical devices. Our team of
seasoned litigators includes physician / attorneys and nurse / attorneys. As
reported in national media such as USA Today, Jet Magazine,
the Washington Post, and Dateline NBC, our
lawyers have won substantial legal compensation for patients and victims in
nationwide lawsuits.
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Read More About Our Verdicts & Settlements
We encourage you to contact our lawyers today for an immediate
free claim evaluation. You may be eligible to participate in a class action
lawsuit on behalf of patients who have been injured, or who have died, due to
the serious malfunction of Guidant ICDs. Call 1-888-4-MEDLAW or complete our
online claim evaluation form.
If you have one of the recalled Guidant defibrillators, contact your
doctor immediately to discuss your medical options. For any given patient there
are numerous alternatives, your cardiologist can recommend an appropriate course
of action individualized for the patient's health concerns. If you feel an
electrical shock from a device, or if there is an audible beeping coming from
the device, it may mean the defibrillator is damaged.
FDA advises patients to take the following steps:
- If you have not already been notified,
contact your doctor to determine if you have an affected PRIZM 2, CONTAK
RENEWAL, or CONTAK RENEWAL 2 device.
- Continue to keep your regular doctor
appointments.
- If you feel an electrical shock from your
device, immediately contact your doctor.
- If there is an audible "beeping" from your
CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to
the nearest emergency room. Beeping may mean that your defibrillator is
damaged.
Guidant also recently informed FDA that it is
recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT,
RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to
a memory error, which may affect device performance. We are currently
investigating this information.
If you have any questions about your legal rights, please contact us to speak
with one of our lawyers. Recognized among the most distinguished law firms in
the United States in the Martindale-Hubbell® Bar Register of Pre-eminent
Lawyers,™ Janet, Jenner & Suggs, LLC has won record breaking verdicts and
settlements through its aggressive advocacy.
GUIDANT DEFIBRILLATOR RECALL NEWS & UPDATES:
Guidant Put Speed Ahead of Heart-Device Quality, Ex-Worker Says
Bloomberg - January 13, 2006
...Guidant Corp. reduced training and emphasized production speed
over quality at its troubled factory making implantable heart
devices in St. Paul, Minnesota, according to a 14-year worker who
trained others there. Management set ``unrealistic'' goals for
production of pacemakers and defibrillators and offered incentives
for meeting them...
Implant Recalls Heighten Anxiety
Pittsburgh Post-Gazette - August 21, 2005
... Guidant knew of risks ... But the scrutiny of Guidant and other
defibrillator makers may be just getting under way. In May, the New
York Times said the Indianapolis corporation sold a defibrillator
model it knew had a small risk of malfunctioning, but didn't issue
warnings about it for three years.
Problems
with heart device raise questions
St. Petersburg Times - August 7, 2005
... A group is debating how soon doctors should be notified when
flaws are reported.
Guidant
And FDA Could Face Senate Scrutiny
WCCO.COM - July 31, 2005
... Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance
Committee, asked the FDA to provide documents relating to Guidant's
series of recalls.
New
Report of Problems at Guidant
New York Times - July 30, 2005
... A filing, which was first publicly disclosed earlier this month,
shows that a heart patient implanted with a specific type of Guidant
unit "presented to a hospital" around the beginning of
March after suffering cardiac arrest, an often fatal condition that
the device known as a defibrillator is intended to prevent. This
happened two weeks before a college student with a flawed heart
device died in March.
As Many As 69 Pacemaker Models May Have Failed; Two Deaths and
Dozens of Product Failures Led to Recalls
Consumer Reports - July 26, 2005
... On July 22, the Food and Drug Administration classified
Guidant's recall as Class I, the most serious kind. As many as 69
pacemakers may have failed according to Guidant. All the reported
failures occurred in devices that had been implanted in patients for
at least 44 months.
Guidant adds five additional defibrillators
to warning
SunHerald.com - July 24, 2005
... A second safety warning from Guidant Corp., one of the nation's
largest medical device manufacturers, urged doctors to stop using
five defibrillator models because they could malfunction and may
have to be recalled. Indianapolis-based Guidant announced its second
worldwide safety advisory in a week on Friday, after voluntarily
recalling seven defibrillator models last week. The pager-sized
devices sense an irregular heart rhythm and shock the heart back
into correct beating. At least 74,900 defibrillators are now under a
company warning.
The warnings include the Contak Renewal 3 model, the company's
largest seller, and Contak Renewal 4, as well as the Renewal RF. It
also covers the Renewal 3 and the Renewal 4 AVT models.
Guidant's Defibrillator 'Fix' May Raise
Other Risks
Indianapolis Star - July 23, 2005
The
Guidant Corporation said Friday that one of its recent
recommendations for correcting problems with some of its
defibrillators might actually increase the risk of malfunction in
three models implanted in about 21,000 heart patients. The company
said a programming change that it suggested to doctors in June might
"significantly increase" the risk that a magnetic switch in the
Ventak Prizm, Vitality and Contak Renewal devices would become stuck
and prevent them from providing treatment.
UPDATE 2-Guidant revises recommendations on
ICD fix
Reuters - July 22, 2005
... CHICAGO, July 22 - Guidant Corp. on Friday revised its
recommendations about how to handle problems with some of its
recalled implantable heart devices because of increased risk to
patients.
F DA Announces
Guidant’s Class I Pacemaker Recall
U.S. Food & Drug Administration
Website - July 22, 2005
... The U.S. Food and Drug Administration (FDA) is notifying
health care providers and patients that Guidant Corporation is
voluntarily recalling certain pacemakers. 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.
FDA Gives Highest Warning About Certain Guidant Defibrillators
The government says a malfunction in some of the
Guidant Corporation defibrillators recalled recently could cause
serious injury or death. ...
Guidant defibrillators recalled
A series of failures in Guidant Corp. defibrillators
that resulted in two deaths prompted the company to issue warnings
to doctors ...
FDA halts expansion of network to monitor medical device safety
North Reading medical technology consulting firm,
said data from more hospitals might have led to earlier detection of
problems with Guidant's defibrillators. ...
Lawsuit claims faulty implanted defibrillator caused death
The lawsuit, filed Wednesday in Duval Circuit Court,
claims Guidant, of Indianapolis, was aware of problems with its
defibrillators for about three years, but ...
FDA: Some Guidant Defibrillators Recalled
The FDA says Guidant Corp. is recalling certain
implantable defibrillators and cardiac resynchronization
defibrillators. ...
New worry for heart patients as Guidant defibrillators are ...
The latest Guidant safety announcement affects the
Contak Renewal 3 model, Contak ... At least 74,900 defibrillators
worldwide are now under a safety warning, with ...
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