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 distributed affected devices in the latest recall between March 6, 2012, and May 19, 2023. They initiated the recall on June 5, 2023, according to the FDA notice.
The Cardiosave IABPs treat acute coronary syndrome, cardiac and non-cardiac surgery or complications of heart failures in adults. Their authorization covers use in healthcare facilities.
These devices inflate and deflate intra-aortic balloons to provide temporary support to the left ventricle through counter-pulsation. Once the balloon is positioned in the aorta, the pump works in synchrony with the electrocardiogram or arterial pressure waveform. It makes the balloon inflate and deflate at the right time during the cardiac cycle