On October 15, 2007, the Food and Drug Administration issued a Class I Recall involving the Medtronic, Inc., Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949. This recall specifically relates to those leads manufactured from September 2004 through October 15, 2007. This action does not affect Medtronic pacemaker patients.
In March [...]
Defective lead recall
On October 15, 2007, Medtronic suspended sale of their Sprint Fidelis Defibrillator leads (Models 6930, 6931, 6948, 6949) after receiving reports of 5 fatalities. I am glad to report that Metronic finally took the appropriate action by suspending global sales of the defective leads and recalling the leads already on the market. [...]
Defective lead recall
On October 15, 2007, Medtronic suspended sale of their Sprint Fidelis Defibrillator leads (Models 6930, 6931, 6948, 6949) after receiving reports of 5 fatalities. I am glad to report that Metronic finally took the appropriate action by suspending global sales of the defective leads and recalling the leads already on the market. [...]
