The Food and Drug Administration has shared updated warnings concerning a heart pump used in a variety of medical care situations.
FILE - A sign for the U.S. Food and Drug Administration is displayed outside their offices in Silver Spring, Md., Dec. 10, 2020. The FDA identified over 66,000 Impella Left Sided Blood Pumps, manufactured by Abiomed, as a Class I recall. They said this is the most serious type of recall and that use of the devices "may cause serious injuries or death." However, it is important to note that the recall is considered a correction and not a product removal.
An Abiomed spokesperson provided The National Desk with the following statement about the Impella devices: The spokesperson also shared details surrounding the actions taken by Abiomed to raise awareness and mitigate the risk of left-ventricle perforation, which the company says is "a rare and known complication during invasive cardiology procedures.
With patient safety top of mind, our IFU was updated with stronger technical guidance around implantation and repositioning and shared broadly.
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