FDA Warning for St. Jude Defibrillators - Consumer Justice Foundation

FDA Warning for St. Jude Defibrillators

Written by Faith Anderson on January 15, 2013
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Problems With St. Jude’s Medical Devices

Defibrillators are medical devices implanted in the chest to correct dangerous heart rhythms in patients. Unfortunately, St. Jude has been plagued by problems with its defibrillators and defibrillator leads for years, which could put the lives of patients using these devices at significant risk. Despite the problems found at the company’s Sylmar, California plant, the FDA has not recalled any of St. Jude’s products, and the firm will continue manufacturing and shipping products from the facility. However, under the terms of the FDA’s warning letter, the agency will not approve new product lines at the plant until the problems addressed in the letter are corrected. St. Jude said in a regulatory filing that it is working to correct the problems at its California plant, and does not expect the FDA citation to affect its financial results.

An Experienced Product Liability Attorney Can Help

St. Jude has struggled in recent years to resolve problems associated with the wires that are used to attach its implantable defibrillators to the heart. According to a recent report, St. Jude was aware of problems with its Riata defibrillator leads in 2005, but it wasn’t until 2010 that the company finally discontinued sales of the faulty wires. The following year, the FDA declared a Class I recall of the Riata leads, due to the risk of the wires penetrating their insulation and possibly preventing patients from receiving critical therapy. Unfortunately, prior to the recall, approximately 227,000 potentially defective St. Jude Riata wires were implanted in patients worldwide. If you have been implanted with a St. Jude defibrillator and you have since suffered a major side effect of the medical device, don’t hesitate to protect your legal rights. Contact a reputable lawyer in your area to discuss your legal options and pursue the compensation you deserve.

Posted Under: FDA - Food and Drug Administration
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