Medscape

FDA Update on Maquet/Datascope Intra-aortic Balloon Pump Failures

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 ...
Medscape

Field Correction for Datascope Intra-aortic Balloon Pumps

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 ...
Becker's Hospital Review

FDA recalls 2K Datascope heart balloon pumps

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 ...
Becker's Hospital Review

More heart balloon pumps recalled after unexpected shutdowns

Getinge subsidiary Datascope has recalled thousands of Intra-Aortic Balloon Pumps in 2023, and in the latest notice, the FDA labeled the issue as Class I because of unexpected shutdowns. On Aug. 10, ...
FierceBiotech

FDA discloses patient deaths, safety reports from recalled balloon heart pumps

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 ...
TCTMD

Maquet Recalls Intra-Aortic Balloon Pumps Due to Potential Failure of Power Supply

— 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 ...
Healio

Hybrid intra-aortic balloon pump recalled

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 ...
Healio

FDA designates recall of two intra-aortic balloon pumps as class I

Please provide your email address to receive an email when new articles are posted on . Datascope/Maquet/Getinge intra-aortic balloon pumps recalled due to risk for unexpected shutdown. The FDA has ...
BioWorld

FDA sees lack of alternatives for Datascope balloon pumps despite recalls

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 ...
Business Wire

United States Market Report for Intra-Aortic Balloon Pumps 2018 - Research and Markets

DUBLIN--(BUSINESS WIRE)--The "US Market Report for Intra-Aortic Balloon Pumps 2018 - MedCore" report has been added to Research and Markets' offering. An intra-aortic balloon pump system is used for ...
TCTMD

MAQUET Cardiovascular Announces FDA 510(k) Clearance and CE Mark for the Cardiosave Intra-Aortic Balloon Pump

Mahwah, NJ-- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced U.S. Food & Drug Administration (FDA) 510(k) clearance and CE mark today at the 2011 Transcatheter ...