Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
Device Name : Orsiro
Size : 2.75/40
REF number : 391240
LOT : 02152670, 02152671
Device Name : Orsiro
Size : 3.0/40
REF number : 391241
LOT : 02152672, 02152673