Medtronic Lead Recall
Medtronic, the world's largest medical technology company, recently became a hot topic in the news because of its recall of Sprint Fidelis lead which used to deliver therapy in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). On October 2007, the company issued a voluntary market suspension to remove its line of Sprint Fidelis defibrillation leads from the market.
The lead serves as an insulating wire to carry electric impulses to the heart. Medtronic removed the Sprint Fidelis lead from the market from the market because of its excessive failure rate. The lead too is prone to fracturing and can make the defibrillator deliver unnecessary shocks to the patient. A patient can know if her lead is recalled by checking the patient ID or wallet card. If the card contains the four sets of numbers under the column Model #, 6949, 6948, 6931, or 6930, then the patient has the recalled lead. It was reported that at least five people died in relation to using fractured Sprint Fidelis leads and more than 1,600 injury and electric shock reports have also been filed for the past two years. Although being confronted by a dozen of lawsuits, Medtronic asserts that the recalled lead is not hazardous at all; it was only pulled out because of its high failure rate.
