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 ...
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 ...
— Datascope Corp./Maquet initiated a voluntary worldwide field correction of some of its intra-aortic balloon pumps (IABPs) due to a potential mechanical failure of the fan assembly associated with ...
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.
The FDA has disclosed over 60 additional safety reports relating to intra-aortic balloon pumps manufactured by Maquet and Datascope, including two patient deaths, following a Class I recall this past ...
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 ...