FDA Says Abiomed Reported No Serious Injuries, 3 Deaths Associated With AIC Issue

ReutersJul 1, 2025 7:52 PM

July 1 (Reuters) -

FDA: AWARE THAT ABIOMED ISSUED LETTER TO AFFECTED CUSTOMERS RECOMMENDING ALL AUTOMATED IMPELLA CONTROLLERS (AIC) HAVE UPDATED INSTRUCTIONS FOR USE
FDA: AS OF JUNE 13, ABIOMED REPORTED NO SERIOUS INJURIES AND 3 DEATHS ASSOCIATED WITH AUTOMATED IMPELLA CONTROLLER ISSUE

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