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# Early Alert on Abiomed Impella RP Heart Pumps
- URL: https://www.fdaweb.com/early-alert-on-abiomed-impella-rp-heart-pumps/
- Published: 2026-02-03T12:00:00.000Z
- Updated: 2026-09-14T15:32:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160600

FDA has issued an [early alert](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-heart-pump-issue-abiomed?utm%5Fmedium=email&utm%5Fsource=govdelivery) to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used to support patients with acute right heart failure. The alert, which applies to all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices, comes after Abiomed identified a malfunction risk involving the devices’ differential pressure (dP) sensor.

According to FDA, sensor drift over time can cause the Automated Impella Controller (AIC) to display inaccurate clinical information, including pump flow readings and placement signals. Abiomed says it has sent an Urgent Medical Device Correction letter to affected customers recommending updated use instructions while the agency continues to evaluate the issue.

The dP sensor measures the pressure difference between the inlet and outlet of the pump and is used to calculate several displayed parameters, including pump flow, pulmonary artery placement signals, pulmonary artery pulsatility index (PAPi), and central venous placement signals, according to the alert. If sensor drift occurs, those values may become inaccurate, potentially leading clinicians to make inappropriate clinical decisions such as incorrect P-level adjustments or unnecessary pump exchanges, it says.

As of 1/15, Abiomed has reported 22 injuries and no deaths associated with the issue.