FDA confirms more recalls for Johnson & Johnson heart pumps due to malfunction risk

The FDA has finalized three new Class I recalls for several Johnson & Johnson MedTech Impella RP heart pumps due to malfunctioning differential pressure sensors that can cause inaccurate readings, potentially leading clinicians to make incorrect treatment decisions. Although no devices need to be returned, the FDA urges users to consult updated instructions for use (IFU) to understand risks, as 22 patient injuries have been reported, though no deaths. The specific sensors do not affect the pump’s hemodynamic support, but continuous monitoring and adherence to the IFU are critical for patient safety.