Datascope/Maquet have initiated a worldwide recall of certain intra-aortic balloon pump (IABP) systems to address potential electrical test failures. The action involves CS100, CS100i, and CS300 IABPs ...
SILVER SPRING, MD — Datascope Corp/Maquet has initiated a worldwide "field correction" of certain intra-aortic balloon pump (IABP) systems to address potential electrical test failures, a MedWatch ...
SILVER SPRING, MD —The US Food and Drug Administration has expanded the June 2017 onsite field correction issued for Datascope/Maquet intra-aortic balloon pumps (IABPs) to a class I recall, the agency ...
The US Food and Drug Administration (FDA) has alerted users of Datascope Corp/MAQUET’s Cardiosave hybrid intra-aortic balloon pump (IABP) to a “design issue” that enables fluids to leak into the ...
The U.S. FDA reported yet another recall of intra-aortic balloon pumps made by Datascope Corp., an unfortunate development for patients in need of these devices that are still on the FDA’s list of ...
The US Food and Drug Administration (FDA) said Tuesday that since notifying physicians of particular intra-aortic balloon pump (IABP) device failures last November, two more patients have died and one ...
The US Food and Drug Administration (FDA) on Tuesday designated Getinge’s Maquet/Datascope recall of intra-aortic balloon pumps (IABPs) as Class I after five patient deaths were reported since 2016.