FDA Classifies the Abiomed Automated Impella Controller Removal as a Class I Recall on November 9: Three Controller Models Affected, With No Serious Injuries or Deaths Reported as of September 8
Washington — The Food and Drug Administration updated its communication on November 9 to say the Abiomed Automated Impella Controller removal has been classified as a Class I recall. The agency says this is the most serious type of recall, the device may cause serious injury or death if use continues, and this recall involves removing devices from where they are used or sold.
The affected products are three Automated Impella Controller models, product numbers 0042-0000-US, 0042-0010-US and 0042-0040-US, limited to specific consoles. Abiomed sent a letter to affected customers on September 18 recommending removal.
The agency relays Abiomed statement that a retrospective review of servicing records identified certain controllers requiring hardware, firmware or software updates to address quality issues with potential safety implications.
As of September 8, 2026, Abiomed had reported no serious injuries or deaths associated with this issue. On the timeline, the FDA issued an Early Alert on September 23 about the potentially high risk device issue, and updated the communication on November 9 with the classification, with affected products and recommendations unchanged. This report relays only the facts in the communication, without individual treatment advice.
Published by GSM · USA (original Chinese edition)
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