Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure
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.
Thu Nov 18 2021
Recalled Product
- Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs
- Product Codes and Lot Numbers: See Recall Details
- Devices Recalled in the United States: 137 battery packs
- Distribution Date: September 23, 2017 to August 17, 2021
- Date Initiated by Firm: September 21, 2021
Device Use
The CardioSave Hybrid/Rescue Intra-Aortic Balloon Pumps (IABP) are cardiac (heart) 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.
Reason for Recall
Datascope/Getinge/Maquet is recalling this product due to the risk of the battery failing and having a shortened run-time due to substandard batteries not meeting performance specifications being released to customers, which may cause the device to stop working when operated by battery only.
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/Getting/Maquet reports receiving six 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.
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