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US regulator issues highest alert for heart pump linked to 49 deaths

Pelican Press

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US regulator issues highest alert for heart pump linked to 49 deaths

The warning letter resulted in the Abiomed issuing a “Urgent Medical Device Correction letter” late least year, containing revised instructions for using the heart pump correctly, including how to position the pump’s catheter or use imaging when turning it during procedures, the FDA said.





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