The device, the Impella 5.5 with SmartAssist, is intended to help pump a heart for up to 14 days after cardiogenic shock following a severe heart attack, open-heart surgery or cardiomyopathy.
The recall is labeled Class I, the most serious type, because leaking fluid can lead to halted therapy and serious injury or death in critical patients, the FDA said in a news release. As of June 5, Abiomed has noted 179 complaints, three injuries and zero deaths connected with the recall.
“The latest versions of the Impella 5.5 with SmartAssist Sets with the preinstalled sidearm retainer and the new yellow luer are not part of this recall,” a spokesperson told Becker’s.
Its product code is 0550-0008 and the devices were distributed between Sept. 28, 2021, and March 6, 2023.
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