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FDA Issues Warning to St. Jude Medical About Heart Defibrillators

Posted on in Defective Medical Devices

Bloomberg Businessweek is reporting that Minnesota-based St. Jude Medical has received a warning letter from the U.S. Food & Drug Administration (FDA) regarding its implantable heart defibrillators, which it manufactures at a plant in Sylmar, California. These heart defibrillators are medical devices that can be implanted in a person's chest in order to correct abnormal or dangerous heart rhythms.

FDA's concerns arose when inspectors visited the plant in October, 2012, and allegedly found inconsistencies in the defibrillator manufacturing process and quality-control procedures. St. Jude claims that it is working to fix the problems identified by the FDA. In the meantime, the FDA will not approve any new product lines to be manufactured at the California plant until the problems are completely resolved. However, neither the heart defibrillators nor any other St. Jude product has been recalled by the FDA.

Unfortunately, these are not the first problems that St. Jude has encountered in recent years. In late 2011, St. Jude recalled its Rialta wires, which are used to attach the defibrillator to the heart, due to concerns about the insulation of the wires. In 2012, the medical device company recalled two other defibrillator wires, QuickSite and QuickFlex, amidst similar quality concerns. Currently, about 79,000 Rialta wires are implanted in U.S. patients. The FDA previously ordered St. Jude to conduct a three-year study of the wires in order to determine the risk of insulation failure.

The potential failure of these medical devices can be scary for consumers, as many patients already have had these allegedly defective devices implanted inside their bodies. If these devices do fail, then the patients who have had the devices implanted may face life-threatening medical conditions as a result.

If you or a loved one has been adversely affected by a St. Jude defibrillator or wire, or by any type of defective medical device, you will need to contact an experienced defective medical device attorney for help. You may be entitled to compensation for your losses if injury has occurred to you as a result of having these devices implanted.

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