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Guidant

Guidant Implantable Cardioverter-Defibrillators (ICDs)

Boston Scientific/Guidant Corporation (Guidant) produces Implantable Cardioverter-Defibrillators (ICDs). ICDs are implanted into the patient's body and monitor the patient's heart rhythm, shocking the heart when there are life-threatening arrhythmias. Please see the Article on ICDs, discussing the purpose and use of ICDs.

Due to malfunctioning, the FDA issued a notification to the public of the recall of certain Guidant ICDs. In the FDA's October 13, 2005 update, it indicated that the following Guidant products were being recalled:

  • VENTAK 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 indicated that malfunctions occurred due to a shorting of the defibrillation pulse back into the circuit. The company said that this shorting occurred because of a degraded insulation in the defibrillators. This meant that during an episode of irregular heart rhythms, the defibrillator would not deliver the necessary shock to the heart. This malfunction posed a serious, life-threatening danger to individuals implanted with defibrillators. Prompting the recall by Guidant was the fact that there had been deaths due to the malfunctioning.

Additional Recall

Guidant issued another recall on April 10, 2007 of about 73,000 ICDs and Cardiac Resynchronization Therapy Defibrillators. The problem was that a capacitor was faulty, causing the batteries to deplete sooner than they were supposed to. The devices affected by the recall included the following:

  • CONTAK RENEWAL 3 HE CRT-Ds, Model H177 and H179,
  • CONTAK RENEWAL 3 CRT-Ds, Model H170 and H175,
  • VITALITY DR ICDs, Model T165,
  • VITALITY 2 VR ICDs, Model T175,
  • VITALITY AVT ICDs, Model A155
  • VITALITY DS DR ICDs, Model T125
  • VITALITY EL DR ICDs, Model T135

Although no serious injuries or deaths were reported, as of March 30, 2007, Guidant indicated that there were 19 incidents where Guidant's devices had batteries that lost power sooner than expected.

Guidant's Recommendations

Guidant recommended that patients who had Guidant-manufactured ICDs implanted in them take precautionary steps, such as scheduling an appointment with your doctor if you have any of the affected devices, and replacing any device that showed a likelihood of failure.

If you or someone you love has suffered an injury due to a device that has been recalled by Guidant, protect your rights by contacting Anderson Law Offices, LLC for a free initial consultation.

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