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# FDA Alert on Abiomed Impella Controllers
- URL: https://www.fdaweb.com/fda-alert-on-abiomed-impella-controllers-2/
- Published: 2025-09-23T12:00:00.000Z
- Updated: 2026-09-14T15:22:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159922

FDA has issued an early alert after becoming aware that Abiomed had issued a letter to affected customers recommending certain Automated Impella Controllers be removed from where they are used or sold. “Abiomed identified Automated Impella Controller purge pressure issues due to purge retainer failures, such as cracks,” the [alert](https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-automated-impella-controller-purge-retainer-fixation-issue-abiomed?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “Abiomed determined that the force users apply during purge disc insertion/removal contributes to the purge retainer failures.”

The alert says that failures impacting purge pressure and detection of the purge disc may lead to errors, alarms, and potential interruptions in hemodynamic support when the controllers may need to be replaced. Such failures may result in a “pump stop with resultant loss of hemodynamic support,” it says, adding that a loss of hemodynamic support poses a serious risk to patient health and may lead to permanent impairment or death.

To date, Abiomed has reported five serious injuries associated with the issue.

The controller is the primary user control interface for Impella Catheters, which are temporary heart pumps used to reduce the work of the heart's left ventricle.