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 ...
The US Food and Drug Administration (FDA) continues to receive reports of device failures associated with Maquet/Datascope Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS100/CS100i intra-aortic ...
More than 2,000 heart balloon pumps are part of a Class I recall issued by the FDA. The two models being recalled — Cardiosave Hybrid and Rescue pumps made by Datascope, a subsidiary of Getinge — have ...
— 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 ...
Two deaths, one serious injury and more than 60 medical device reports have been linked to Maquet/Datascope’s intra-aortic balloon pumps in the past year, the FDA warned healthcare providers in a Nov.
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 ...
Please provide your email address to receive an email when new articles are posted on . The FDA announced that Maquet Datascope Corp. has recalled a hybrid intra-aortic balloon pump due to a design ...
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 U.S. FDA recently posted another round of recalls for the Cardiosave line of intra-aortic balloon pumps (IABPs) by Datascope Corp., advising users to make sure they have a backup unit at the ready ...
Please provide your email address to receive an email when new articles are posted on . Datascope/Getinge announced a recall of its intra-aortic balloon pumps due to risk for blood entering the pump ...
The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) have been hit with another recall by the manufacturer (Getinge/Datascope), this time due to damage to the balloon ...
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