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Home » Abiomed Recalls Labeling for Its Impella RP Smart Assist Catheter
Abiomed Recalls Labeling for Its Impella RP Smart Assist Catheter
The FDA cites inadequate product labeling as the reason for marking Abiomed’s June recall of its Impella RP Flex with Smart Assist system catheter as class I, the most serious type of recall as use of the device may cause injury or death.