FDA warns that Johnson & Johnson heart pump sensors may malfunction—22 injuries reported

February 3, 2026 - 19:08

The U.S. Food and Drug Administration (FDA) has issued a new safety warning concerning certain heart pump sensors manufactured by Johnson & Johnson. The agency reports that the devices may malfunction, potentially leading to inaccurate readings. This flaw has already been linked to 22 reported injuries.

The sensors in question are used with specific heart pump systems to monitor a patient's cardiac status. A malfunction could cause the system to display incorrect data regarding the heart's function. This presents a serious risk, as clinicians or patients might make unnecessary and potentially harmful adjustments to treatment based on faulty information.

The FDA is actively investigating the issue to determine the root cause and the full scope of the problem. The agency emphasizes that it is continuing to evaluate all available data. In the meantime, healthcare providers are being alerted to monitor patients using these sensors closely and to be aware of the potential for inaccurate readings that do not match a patient's clinical condition. Patients with concerns are advised to contact their healthcare provider immediately and not to alter their therapy without direct medical consultation.