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Medical science has made great advances in the last few decades. Not the least of the significant advances has been the rapid growth of coronary interventional procedures and introduction of heart devices that have offered enhancements and cost advantages over older surgical procedures such as coronary bypass operations. With advances in interventional technology, new frontiers have been entered in the world of medical science.
Doctors and heart patients rely on an assortment of life-sustaining heart devices, including heart valves, pacemakers, and defibrillators. The recent recall of several implanted defibrillator models has placed tremendous attention on heart implant industry and the FDA which is responsible for overseeing medical devices. A September 2005 news article by the Associated Press reported that research sponsored by the Food and Drug Administration concluded that about 20 of every 1,000 defibrillators implanted are malfunctioning, and defects led to 31 deaths between 1990 and 2002. The reports also concluded that the deaths represent only a fraction of the more than 400,000 defibrillators implanted during those years.
Heart valve surgery is one of the more common heart surgeries, successfully performed on thousands each year. Artificial heart valves are typically mechanical (manufactured) valves or made from human or animal tissue. While mechanical valves may last longer, some people receiving a mechanical valve may develop blood clotting or other problems, and anticoagulant blood thinning medication is often prescribed to prevent such problems.
Heart stents are typically tiny wire mesh tubes that are inserted into blocked arteries in the heart and then expanded to increase the diameter of the blood vessel and create a free-flowing passage for blood. Heart stents reduce the need for repeat operations to unclog arteries and lower the risk and severity of heart attacks and strokes.
Most heart devices are safe and have helped save and improve the lives of many heart patients. However, in recent years a number of heart devices have been subject to warnings by the U.S. Food and Drug Administration (FDA) or have been recalled due to safety concerns and reports of injuries or deaths. A July, 2005 report concluded that medical devices need closer scrutiny and that FDA oversight of some devices is deficient.
Recent heart device, pacemaker, and defibrillator recalls include Guidant device and defibrillator recalls, Boston Scientific Taxus Express Heart Stents and
St. Jude's Silzone Heart Valves. In addition, warnings have been issued for Cordis CYPHER Heart Stents. For a list of recalled heart devices, click here.
If you or a loved one received a recalled or defective heart device, you may confidentially complete our online claim form. We will respond to your inquiry at no cost or obligation within one business day.
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| COMPLETE OUR CLAIM FORM BELOW FOR A FREE REVIEW |
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If you or a loved one have received a Medtronic or Guidant heart device or suffered a serious injury or side effect after receiving a heart device, please fill out the form and a lawyer will review your information within 24 hours.
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| ABOUT US : Representing Those Seriously Harmed By Unsafe or Defective Heart Devices |
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Our law firm represents individual and class action plaintiffs in large product liability and consumer protection cases, nationwide. Our law firm has been involved in significant and complex medical device cases, including heart device cases, Silicon Gel Breast Implant Litigation, Norplant Birth Control Device Litigation, Sulzer Hip Implant Device Litigation, and Guidant heart device claims. For general information about drug safety visit our DrugRecalls.com website.
Our law firm has been involved in a wide range of legal matters concerning heart devices and related medical device products throughout the United States. Our law firm is currently investigating claims involving Guidant heart devices, Guidant pacemakers, and Guidant defibrillators.
For more information about us you may visit our firm website.
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If you or a loved one have suffered an injury or experienced serious side effects after receiving a heart device, please complete our FORM or CALL 1-800-448-5800 |
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October 15, 2007:: MEDTRONIC SPRINT FIDELIS LEAD RECALL:
The FDA has issued a Class I Recall of Medtronic Sprint Fidelis leads which attach defibrillators and other ICDs to the heart, due to fracture risks that can result in unwarranted shocks being applied to the implanted patient's heart.
Click here for more info.
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May 2, 2007:: The U.S. Food and Drug Administration (FDA) issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns. The products include pediatric heart valves, tube-like devices for blood flow (conduits), surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.
Click here for more info.
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December 6, 2006:: Study shows that patients who have received a drug-coated stent to prop open an artery
face double the risk of heart attack or death after they stop taking an
anti-clotting drug. The findings mean patients may need to stay on medication beyond the
three to six months currently recommended and possibly for the rest of
their lives.
Click here for article.
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September 28, 2006::
The Food and Drug Administration is considering not using the word "recall" to warn patients and doctors about defective pacemakers and defibrillators.
Click here for article.
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September, 2005 :: The biggest American maker of heart devices, Medtronic, reported that is considering making available to doctors and patients some of the data about product malfunctions.
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September, 2005 :: FDA research concludes that about 20 of every 1,000 defibrillators implanted are malfunctioning, and defects led to 31 deaths between 1990 and 2002.
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July 18, 2005 :: Guidant announces that replacements might be needed for nine pacemaker models.
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July 1, 2005 :: FDA classifies Guidant Defibrillator recall.
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June 24, 2005 :: Guidant advises doctors to stop implanting defibrillators due to safety problems.
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June 17, 2005 :: Guidant recalls nearly 50,000 of its cardiac defibrillators implanted in patients worldwide because of potential malfunctions in the heart devices.
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April 2005 :: Laerdal Medical Corporation and the FDA notified healthcare professionals of a voluntary recall of all lots of CM 100-Heartstart Adapter Cable, Cat. No. 920650 (Adapter Cable). Wires within the defibrillator adapter cables are susceptible to breakage that prevented delivery of defibrillation shocks.
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July 2004 :: Boston Scientific Corporation announces the recall of over 96,000 heart stents after reports of 3 patient deaths and more than 40 serious injuries caused during implantation of the stents.
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HeartDevice.com is a resource for consumers and lawyers about Medtronic and Guidant recalls, heart device recalls, heart valve, heart stent, heart wire, heart lead, pacemaker, and defibrillator recalls, warnings, and lawsuits.
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