April 12, 2007
On April 12 th 2007, Boston Scientific/Guidant and the FDA recalled a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families. This new recall includes about 73,000 implantable cardiac resynchronization therapy defibrillators and cardiac defibrillators due to faulty capacitors. While this recall is similar to the recall of May 2006, this time the failure modes and patient outcomes differ. The capacitors have been causing accelerated battery depletion and reducing the time between the elective replacement indicators and end of life to less than three months.

Guidant Recall

The Food and Drug Administration has announced that it has recently received reports about new patient deaths caused by a fatal complication linked to short circuiting in defibrillator and pacemaker heart devices manufactured by Guidant Corporation, which brings the number of known deaths associated with the deadly defect to seven.

On June 17, 2005, Guidant Corporation recalled its cardiac defibrillators implanted in 50,000 patients around the world due to potentially fatal malfunctions of the devices. There are approximately 38,000 patients in the United States with Guidant defibrillators, which reports indicate have failed 45 times and are responsible for at least two deaths since May 30th.

The Guidant Defibrillator Recall includes the following models of cardiac defibrillators:

• Guidant Prizm 2 DR
• Guidant Contak Renewal and Contak Renewal 2
• Guidant Ventak Prizm AVT
• Guidant Vitality AVT
• Guidant Renewal 3 AVT and Renewal 4 AVT ICDs

Ventak Prizm 2 DR | Contak Renewal | Ventak Prizm AVT | Vitality AVT | Renewal 3 AVT | Renewal 4 AVT

Guidant cardiac defibrillators are small devices implanted into the body to regulate the heartbeat in people with risk of heart problems. Small computers detect an irregular heartbeat and shock the heart into the proper rhythm, but critical wiring errors in Guidant defibrillators may cause a short circuit which can overload their delicate wiring. Guidant Prizm AVT, Vitality AVT and Renewal AVT can be serviced at a doctor’s office to reduce this risk, but Prizm 2 DR and Contak Renewal must be replaced in order to eliminate potential hazards. Those at the greatest risk should immediately consult their doctors and continue to have checkups every three months to ensure that the devices are still working properly.

The Food and Drug Administration released a statement stating that they did not require a Guidant Defibrillator Recall, but that they nevertheless supported the decision to address such serious allegations. The fact that this issue was finally addressed is of small comfort to the 50,000 people who continue to live in constant fear that their life-saving medical equipment may fail them when they need it the most.

Guidant Corp knew that there were problems in its Prizm 2 DR model and continued to market it...

Guidant Corp knew that there were problems in its Prizm 2 DR model and continued to market it, but demanded a total redesign of the unit. The company knew the model had failed a small number of times before 2002, but claimed that future revisions would make it safer. Doctors then discovered that Contak Renewal defibrillators built before August 26th, 2004 demonstrated a large risk of shorting out and failing to function properly. Only when presented with two such problems did Guidant act in the best interest of the public and offer to recall and service their defective products. If you or your loved one uses Guidant brand defibrillators, you could be in serious danger. Consult your doctor immediately, but then contact our lawyers right away.

The most common terms people have used in Google to find this web page include: Defibrillator death, Defibrillator malfunction, Defibrillator short circuit, Defibrillator heart attack.

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Latest News:

FDA Issues highest level (class I) warning regarding health risks associated with three of the recalled Guidant implantable defibrillator models as well as a class II warning as to eight other models.
Date Published: July 2, 2005
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Guidant released a statement on June 24, 2005 stating that it is voluntarily advising physicians about important safety information regarding certain devices.
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