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Archive for October, 2007

Defribrillator leads recall: Sprint Fidelis lead fractures

October 24th, 2007. Distribution of two types of defibrillators, Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds), is being suspended by Medtronic as a result of lead fractures. If a lead fractures, defibrillators may deliver unecessary shocks or may not function at all. Issues with the leads was first ... [More >>]

Posted in Personal Injury, Product Liability, Sprint Fidelis Defibrillator Leads

FDA: Statement on Medtronic’s Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads

October 22nd, 2007. (Press Release) Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health: Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety. These electronic wires are prone to fracture in a small number of patients which ... [More >>]

Posted in Personal Injury, Product Liability, Sprint Fidelis Defibrillator Leads

Defect in Sprint Fidelis Defibrillation Leads; Medtronic Halts Distribution

October 19th, 2007. (Press Release) On Monday, October 15, Medtronic, Inc. said voluntarily suspended worldwide distribution of the Sprint Fidelis® family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). The Sprint ... [More >>]

Posted in Personal Injury, Product Liability, Sprint Fidelis Defibrillator Leads

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