Pressure Sensor May Malfunction in Some Impella Devices, FDA Warns

The US Food and Drug Administration today issued an early alert to warn of the possibility that the differential pressure sensor can malfunction in Impella RP with SmartAssist and Impella RP Flex with SmartAssist (Abiomed/Johnson & Johnson MedTech) devices.

The company issued updated use instructions for clinicians in response to the situation, which thus far has been associated with 22 patient injuries.

According to the FDA, if the pressure sensor malfunctions, the sensor values can drift over time. As a result, the pump flow readings displayed on the automated Impella controller, as well as the pulmonary artery placement signal, pulmonary artery pulsatility index, and central venous placement signal, may be inaccurate.

While the issue does not affect the hemodynamic support abilities of the Impella devices, inaccurate readings on the controller have resulted in incorrect P-level flow adjustments and unnecessary pump exchanges.

In the updated use instructions, Abiomed recommends that clinicians refer to and rely on the P-level flow rates listed in the instructions for use rather than the display values on the automated controller. Additionally, they advise monitoring hemodynamics with approved diagnostic devices and verifying positioning of the device with imaging before undertaking clinical interventions based on controller-based readings.