GUIDANT DEFIBRILLATORS RECALL & SETTLEMENT
FDA issues Recall for Certain Guidant Heart Defibrillators
FDA has notified health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.
The devices affected by this 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
Guidant has also recently informed the 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.
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.
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Guidant Defibrillator News Updates
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.
Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.
- PULSAR® MAX Models 1170, 1171, 1270
- PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
- DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
- MERIDIAN® Models 0476, 0976, 1176, 1276
- PULSAR MAX II Models 1180, 1181, 1280
- DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
- CONTAK TR® Model 1241
- VIRTUS PLUS® II* Models 1380, 1480
- INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
* VIRTUS PLUS II and INTELIS II models available only outside the U.S.
Guidant
adds to heart-device alerts; 28,000 patients
effected
USA Today - July 19, 2005
....The nine types of pacemakers, which correct
irregular heartbeats, may fail suddenly or cause a
high rate for too long, Guidant says. It said a
sealing component can degrade, allowing body fluids
into the device.
Update
6: Guidant Warns on 28,000 Pacemakers
Forbes - July 18, 2005
... Guidant Corp.,
already under fire for problems with its implantable
defibrillators, on Monday warned physicians
replacements might be needed for nine pacemaker
models made between 1997 and 2000.
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* You should never
make medical decisions without first checking with
your doctor.
