The FDA today released information on a select voluntary recall from Getinge‘s (PINK:GETI B) Datascope and Maquet of its System CS100, CS100i and CS300 intra-aortic balloon pumps over issues with potential electrical test failures.
Datascope said they received a complaint in which the device failed to initiate therapy, resulting in a patient death. The complaint involved a CS300 IABP device which failed to pump due to electrical test failure code #58, a maintenance code and an autofill failure, according to the FDA notice.
