Medtronic Defibrillator Litigation



On October 15, 2007, Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because the electronic wires are prone to fracture in a small number of patients. The Food and Drug Administration (FDA) then issued a Class 1 recall of the leads. The recall came after Medtronic identified five patients whose death may have been related to a fractured Sprint Fidelis defibrillator lead.  As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company, according to the FDA.  More than 268,000 patients have been implanted with the lead.  The defective Medtronic lead may be connected to Medtronic defibrillator or one manufactured by another company.  Patients are encouraged to contact their physicians for more information.   

If you or a loved one have had a recalled Medtronic lead wire inserted, please contact Lewis & Roberts for a free consultation at 1-888-981-0939.  Our attorneys and legal nurse consultant will promptly review your case for no charge or obligation.  You may also use our contact page to submit your information.  Someone from our firm will promptly return your call. 

How do I determine if I have a recalled Sprint Fidelis Lead? 

Look for 6949, 6948, 6931, or 6930 on your ID or wallet card.

Check you patient ID or wallet card.  If any of the rows under the column marked Model Number have the following four sets of numbers: 6949, 6948, 6931, or 6930, then you have the recalled heart lead.  These numbers may be shown at the beginning of a longer set of numbers and letters on your ID card.  You may also obtain more information from the FDA's consumer update page.