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 ...

Maquet/Datascope intra-aortic balloon pumps (IABPs ... Without specifying which IABP models were involved, the announcement pointed out that the company manufactures Cardiosave IABP Hybrid ...

The FDA announced that Maquet Datascope Corp. has recalled a hybrid intra-aortic balloon pump due to a design issue that allows fluid, such as saline, to seep into the device.

Getinge AB reported that intraortic balloon pumps (IABPs) manufactured by its Datascope subsidiary are in short supply following a recall of some of these devices in 2019. Getinge said manufacturing ...

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 ...

Datascope has received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. This complaint involved a CS300 IABP that did not pump due to ...

affects all lots and manufacturing and distribution dates for the following IABP models: Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS100/100i. No product return is required. Maquet/Datascope ...

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 ...

Getinge Group subsidiary Datascope failed to adequately conduct device design ... The firm also failed to “develop a suitable test” for its Cardiosave intra-aortic balloon pump (IABP) to demonstrate a ...

Please provide your email address to receive an email when new articles are posted on . The FDA announced it has designated a recall of intra-aortic balloon pumps by Datascope/Getinge as class I ...

The two models being recalled — Cardiosave Hybrid and Rescue pumps made by Datascope ... the FDA has issued a recall of these specific balloon pump models. In January 2022, the FDA cited ...

Datascope's counterclaims assert that Abiomed has engaged in a pattern of intentional and widespread false advertising regarding Impella ® compared with IABP in violation of federal and state law.