Guidant defibrillator recall of 73,000 implantable heart devices
Approximately 73,000 more implantable Guidant defibrillators have been recalled as a result of a faulty capacitor which could cause the batteries to deplete sooner than expected. This recall involves the same defective component which has led to prior Guidant recalls.
>>PRIOR NEWS 6/27/06: Guidant Pacemaker and Defibrillator Recall
On April 5, 2007, Boston Scientific announced this new Guidant recall for specific Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). The devices recalled in the United States include:
- Contak Renewal 3 HE CRT-Ds (Models H177 and H179)
- Contak Renewal 3 CRT-Ds (Models H170 and H175)
- Vitality 2DR ICDs (T165)
- Vitality 2 VR ICDs (T175)
- Vitality AVT ICDs (A155)
- Vitality DS DR ICDs (T125)
- Vitality EL DR ICDs (T135)
All of the recalled defibrillators were manufactured by Guidant, which was merged with Boston Scientific in April 2006. Although Boston Scientific has indicated that there were no reports of serious injuries or deaths, out of the 73,000 recalled Guidant defibrillators, they have confirmed at least 19 field events. Boston Scientific sent a Product Advisory Letter to patients who have one the recalled implantable devices and sent detailed information to physicians and clinics regarding performance issues.
The problems which have led to this new Guidant defibrillator recall involve a faulty capacitor received from a supplier which could cause the battery to use energy faster than expected. This could lead to less time available for replacement of the device before it stops working, reducing the time between elective replacement indicator and the end of life for the device to less than three months.
In May 2006 there was a prior Guidant recall which also involved problems with a faulty capacitor from a supplier which could cause the battery to deplete sooner than expected. However, the FDA is treating this as a new recall and not as an extension of the May 2006 recall. Other problems with Guidant heart devices resulted in a large recall in June 2005, from which the company faces nearly 2,000 Guidant recall lawsuits.
The FDA has indicated that most individuals with one of the devices included in this latest Guidant defibrillator recall will not require that the device be removed, but rather will require more frequent follow up medical monitoring. However, some individuals may require replacement and they could face serious risk of injury.
If you, a friend or family member have one of the devices included in this latest Guidant recall, consult with your physician to review the medical treatment options available to reduce the risk of serious injury or death. In addition, you should contact our Guidant recall lawyers to review your legal rights and determine whether compensation from the manufacturer of the defective defibrillators may be available. Request a free consultation.
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