Getinge Issues Worldwide Voluntary Correction of Maquet Getinge Cardiosave Intra-Aortic Balloon Pump

PUBLISHED: Sep 20, 2018
Relevant to: Hospitals

Getinge is voluntarily initiating a worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

There have been no adverse events or deaths attributed to this issue at this time.

See the recall notice, link below, for the list of affected products and for detailed operating instructions for use of the Cardiosave IABP at specific altitudes.

Maquet/Getinge is currently developing a software correction to address the altitude issue. Maquet/Getinge anticipates the installation of the updated software to begin February 2019. A Maquet/Getinge Service representative will contact affected customers to schedule the installation of the updated software.

Customers with questions may contact the company via telephone + 1 (973) 709-7967, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. or via e-mail at Helena.swan@getinge.com.

Adverse reactions or quality problems experiences with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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