The Food and Drug Administration (FDA) has announced a recall of Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs (Datascope/Getinge/Maquet) due to the risk of the battery failing and having a shortened run time.
The Cardiosave Hybrid/Rescue intra-aortic balloon pumps (IABP) are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure. If a patient requires life-supporting therapy with an IABP and the device does not work, or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death. Both Cardiosave Hybrid and Rescue IABP monitors display battery life to the user, prompting intervention with low battery alarms when alternative power sources are indicated.
Datascope/Getinge/Maquet reports receiving 6 complaints and no reports of injuries or deaths related to this issue. However, there is a potential for underreporting, since the end user reporting a failed battery or short battery-run time cannot be aware that they originally received a substandard battery. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Food and Drug Administration (FDA). Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure. October 29, 2021. Available at: click here. Accessed November 2, 2021.