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Another FDA Class I Recall of Cardiosave Hybrid/Rescue IABPs

The 4586 recalled Cardiosave Hybrid/Rescue intra-aortic balloon pumps may shutdown unexpectedly due to electrical failures in the power source path, leading to serious harm. ....

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Another FDA Class I Recall of Cardiosave Hybrid/Rescue IABPs

The coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown, without warnings or alarms to alert the user, the FDA says. ....

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