by The National DeskFILE - A sign for the U.S. Food and Drug Administration is displayed outside their offices in Silver Spring, Md., Dec. 10, 2020. concerning a heart pump that has led to the death of dozens of people.
In Dec. 2023, Abiomed sent impacted customers an Urgent Medical Device Correction letter that asked those using the pumps to follow new and revised warnings:Use imaging when advancing or torquing the pump catheter Notify any other facilities where the products have been forwarded of the updated Instructions for Use
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