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 [...]
The U.S. Food and Drug Administration (FDA) recently asked manufacturers of all Gadolinium-based contrast agents to include a new boxed warning on the product label. These contrast agents are used to enhance the quality of magnetic resonance imaging (MRI) and can place patients at risk for developing a potentially fatal disease known as Nephrogenic Systemic [...]
A jury in Baltimore, Maryland, has ordered a sealant company to pay a 73-year-old man $15.3 million after determining that he developed mesothelioma from exposure to asbestos-containing products made by the company. George J. Linkus worked at Key Highway Shipyard from 1952 to 1959. In 1954, Mr. Linkus moved to the machine shop [...]
Lawsuit filed on behalf of 14-year-old- girl who died after using Ortho Evra patch settles for $1.25 million
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. [...]
