J&J recalls certain heart pump controllers due to hardware issues

May 26, 2026 - 23:42

Johnson & Johnson has issued a recall for certain heart pump controllers after discovering hardware issues that could affect patient safety. The U.S. Food and Drug Administration has classified this as a Class I recall, the most serious type, meaning there is a reasonable chance that the problem could cause serious injury or death.

The recall involves specific models of the company's heart pump controllers, which are used to manage blood flow in patients with severe heart failure. According to the FDA notice, the hardware flaw may lead to the pump stopping or failing to restart, potentially leaving patients without adequate circulatory support.

Healthcare providers and care teams are being instructed to send in their affected equipment so that necessary hardware updates can be performed. The company is working to correct the issue by replacing or repairing the controllers. Patients who rely on these devices are urged to contact their doctors immediately if they notice any warning alarms or changes in pump function.

Johnson & Johnson stated that it is notifying hospitals and distributors about the recall and providing instructions for returning the devices. The company has not disclosed how many units are affected, but the recall is expected to impact a limited number of controllers currently in use. The FDA is monitoring the situation and will update the public as more information becomes available.