Getinge subsidiary Datascope has another serious intra-aortic balloon pump recall

The Cardiosave Hybrid system. [Image from FDA]The FDA issued a notice labeling another recall of Getinge subsidiary Datascope’s Cardiosave pump as Class I, the most serious kind.

This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs). Both devices were subject to two separate Class I recalls in March. The company also initiated a Class I recall for the systems in December 2021.

Datascope/Maquet/Getinge recalled the IABPs due to the potential to shut down unexpectedly. This occurs because of electrical failures in the power management board or solenoid board (power source path). Using an affected pump could cause serious adverse health events, including unstable blood pressure, injury and death.

The recall affects 4,586 devices in the U.S. Datascope/Maquet/Getinge reported 26 complaints with no reports of injuries or death related to the issue. The company and its subsidiaries dis…

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Getinge’s Datascope has another serious intra-aortic balloon pump recall

The Cardiosave Hybrid system. [Image from FDA]The FDA issued a notice determining a recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind.

This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in December 2021.

Getinge’s Datascope subsidiary initiated their latest recall of an estimated 2,300 devices on Jan. 9, 2023. They distributed affected devices between March 6, 2012 and July 20, 2017, according to an FDA notice.

To date, Getinge received 44 complaints related to the latest issue with no reported injury or death.

Get the full story at our sister site, Medical Tubing & Extrusion.

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Recall of Datascope/Getinge/Maquet intra-aortic balloon pump is Class I

[Image from FDA]The FDA determined that the recall of the Datascope/Getinge/Maquet Cardiosave Hybrid and CardioSave Rescue devices is Class I, the most serious kind.

Datascope/Getinge/Maquet designed the CardioSave Hybrid and CardioSave Rescue intra-aortic balloon pumps (IABP) as cardiac assist devices for patients undergoing cardiac and non-cardiac surgery. They are used in adults who have acute coronary syndrome or complications of heart failure.

Get the full story at our sister site, Medical Tubing & Extrusion.

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