FDA Warns Italy's Sorin on Medical Device Leads

The U.S. Food and Drug Administration warned Italian medical device maker Sorin Biomedica that it must report to the agency any adverse events concerning its devices that occur outside the United States.

The warning concerns complaints in Belgium, France, Britain, Japan, Germany and Greece about the company's Isoline defibrillation leads - wires used in implantable cardioverter defibrillators and pacemaker systems.

In a letter, the FDA says that in one case in Belgium the Isoline 2CR6 lead "may have caused or contributed to serious injury."

It also cited problems on testing related to the Situs OTW leads.

Sorin Biomedica devices are marketed in the United States by ELA Medical.