> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Alert on Abiomed Heart Pumps
- URL: https://www.fdaweb.com/alert-on-abiomed-heart-pumps/
- Published: 2026-02-25T12:00:00.000Z
- Updated: 2026-09-14T13:34:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160720

FDA has issued an early alert about a potentially high-risk problem involving certain heart pump components manufactured by Abiomed, warning that a malfunction could lead to pump failure and patient death. The alert concerns specific Generation 1 Impella Purge Cassettes and Impella RP Pump Sets used with the company’s Impella heart pumps. According to FDA, Abiomed has notified customers to remove affected products from use or sale in markets where updated components are available.

FDA says the purge cassette delivers rinsing fluid through the Impella catheter to the microaxial blood pump motor, preventing blood from entering the motor. If a leak occurs, it can trigger a “Purge Pressure Low” alarm on the Automated Impella Controller. If not promptly addressed, it says, a purge leak may result in low purge pressure and biomaterial entering the pump motor, which can cause an unexpected pump stop, leading to loss of hemodynamic support. In critically ill patients reliant on the device for circulatory support, such a failure could result in death, FDA says.