Abiomed has issued a warning about an issue with its Automated Impella Controller devices following a reported patient death.
The issue stems from a manufacturing defect in certain units’ pump driver circuit assemblies, which contain capacitors rated below required specifications, according to an Aug. 27 news release from the FDA.
The use of 25v-rated tantalum capacitors in place of 35v-rated components may result in reduced pump performance or sudden pump failure. In these cases, the device may trigger critical alarms, including “Impella Failure” or “Impella Stopped. Controller Failure.”
A sudden drop in the pump performance could result in hemodynamic instability, loss of circulatory support or death.
Abiomed sent letters to affected customers recommending affected devices be immediately quarantined and not used. As of Aug. 12, one death has been reported, the release said.
In an email shared with Becker’s, Johnson & Johnson Medtech stated, “J&J Medtech is initiating a voluntary recall (removal) of 69 Automated Impella Controllers (AIC) after identifying a capacitor failure that, in rare cases, may lead to decreased pump performance or pump stop. Our first priority is our patients, and we are deeply committed to ensuring the safety and quality of our technologies. We notified impacted customers starting Aug. 21, 2025 and will provide loaner AICs for customer use.”
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