According to the early alert, Abiomed issued an urgent medical device correction to notify affected customers of updated use instructions for all Impella RP with Smart Assist and Impella RP Flex with Smart Assist devices.
Abiomed identified that the differential pressure (dP) sensor in Impella RP devices may malfunction. This can cause sensors to drift over time. If sensor drift occurs, the Automated Impella Controller (AIC) may display inaccurate information. That may include pump flow readings, pulmonary artery (PA) placement signals, pulmonary artery pulsatility index (PAPi) and central venous (CV) placement signal.
Impella’s dP sensor measures the pressure difference between the inlet and outlet of the pump. Abiomed said there is no way to confirm error in the flow calculation directly from pump signals when sensor drift occurs. Inaccurate displayed information on the AIC can result in clinical interventions, including inaccurate P-level adjustments or unnecessary pump exchanges. The dP sensor does not affect the device’s ability to provide hemodynamic support.
The FDA notice says that, as of Jan. 15, 2026, Abiomed reports 22 serious injuries associated with the issue. It reports zero deaths associated with the problem.
On Jan. 27, Abiomed sent all affected customers a letter instructing clinicians to continue monitoring patient hemodynamics with approved diagnostic devices and verify Impella positioning with imaging before clinical interventions.
Clinicians should refer to P-level flow rates listed in the instructions for use and rely on those, rather than the AIC display. They should trend pump metrics to monitor pump performance to identify certain changes.
Latest warning for Abiomed and Impella
The J&J unit has faced a handful of regulatory issues related to the Impella platform in recent years.
Impella, a heart pump system, aims to reduce the work of the heart’s left ventricle. It provides support for the circulatory system so the heart has time to recover. The AIC serves as the primary user control interface for Impella catheters, controlling them and monitoring them for alarms.
Last fall, Abiomed reported five serious injuries and no deaths associated with an issue with AIC purge pressure, leading to purge retainer failures, such as cracks. The company determined that the force users apply during purge disc insertion/removal contributes to the purge retainer failures.
That warning came not long after different FDA communications related to the Impella pump controllers. In July 2025, the FDA alerted providers that Abiomed issued updated instructions for use related to all of its AICs. As of June 13, Abiomed had reported no serious injuries and 3 deaths associated with that issue.
In August 2025, the FDA issued another alert for Abiomed instructing customers to remove certain AICs from use or sale. According to an Abiomed spokesperson, the issue affected 69 AICs globally. As of Aug. 12, 2025, Abiomed reported one death and no serious injuries associated with that issue.
