FDA designates recall of two intra-aortic balloon pumps as Class 1
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The FDA has classified Datascope/Getinge/Maquet’s recall of two intra-aortic balloon pumps for patients undergoing surgery as Class 1, the most serious type of recall.
According to an FDA press release, the recall of the devices (Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs) is due to substandard batteries not meeting performance specifications, resulting in shortened battery runtime, which may cause the device to stop working in mid-use, possibly resulting in serious injury or death for patients using the devices for life-supporting therapy.
The devices are used for therapy in patients undergoing cardiac or noncardiac surgery as well as in patients with ACS or complications of HF. Both devices display battery life to the user and feature low battery alarms when alternative power sources are indicated.
The agency stated in the release that six complaints were filed against the devices, but no deaths or injuries have been reported.
According to the release, adverse reactions and quality problems caused by the software can be reported through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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