FDA Medtronic Recall Updates | Medtronics Lawsuit News

Following the latest court decision involving preemption in the Sprint Fidelis recallMedtronics lawsuit for the recalled Sprint Fidelis leads it is interesting to see the increasing number of reports regarding the inner-workings at the Food and Drug Administration. According to a recent New York Times article, nine government scientists complained to the FDA commissioner regarding FDA managers and their lenient relationship with corporations seeking approval for medical devices.

Internal documents and medical reviews reveal that the agency scientists were critical of the medical device approval process that they felt lacked adequate testing of medical devices. In one specific example, the scientists alleged that an agency supervisor pressured them to change reviews of a breast imaging device among others. The increasing information regarding the inability of the FDA to adequately evaluate medical devices such as the recalled Medtronic Sprint Fidelis leads and drugs is especially disturbing considering that the medical device and pharmaceutical industry has been using the FDA approval process as a shield from any liability for products that turn out to be dangerous.

Sprint Fidelis leads are manufactured by Medtronic, the medical device manufacturer headquartered in Minnesota. Medtronics leads consist of cardiac electrodes which are thin wires. These electrodes connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart.

The Sprint Fidelis leads recall was due to the potential for lead fractures. After reports of fractured leads and at least 5 patient deaths, Medtronic recalled their Sprint Fidelis leads. Patients may be at an increased risk of having their leads fracture or break. If this happens the defibrillator could deliver painful shocks or jolts or fail to operate at all.

We represent all Medtronic recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronics lawsuit attorney will contact you to answer any of your questions.


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Copyright 2008 Fields Law Firm a Medtronic Lead Recall Lawyer. Read Our Disclaimer Representing individuals and families related to Medtronic Sprint Fidelis leads, Medtronic defibrillator lead recall and Medtronic lead extractions. Medtronic recall updates including Sprint Fidelis lead recall, Medtronic lead lawsuit and Sprint Fidelis lawsuit. Medtronic lawsuit and Medtronics recall news and information for Medtronic class action. Serving clients suffering from Medtronic heart defibrillator lead side effects for 6949, 6948, 6931 & 6930 leads in Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, D.C., Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.

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