News We’re Watching: Impella Recall Linked To Deaths, FDA OKs New Sterilization Rules, Boston Sci Plans Expansion

This week, Abiomed announced a class I recall of Impella heart pumps; the FDA released new device sterilization standards; and Boston Scientific planned a $140m new campus in Minnesota.

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• Source: Medtech Insight

The FDA has designated a recall of various Impella Left-Sided Blood Pumps from Abiomed, Inc. as class I, its most serious.

The agency said Abiomed recalled the pumps because the instructions for use (IFU) do not adequately address the precautions clinicians need to take when treating patients who have undergone transcatheter...

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