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…