FDA Issues Early Alert For Johnson & Johnson's Abiomed Heart Pump Controllers

Johnson & Johnson’s (NYSE:JNJ) Abiomed has issued an Early Alert regarding its Automated Impella Controllers (AIC) for Impella heart pumps, a device crucial for patients with severe heart conditions. This alert, issued by the Food and Drug Administration (FDA), highlights a critical safety concern following reports of three deaths.

What happened?

Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC).

Abiomed identified an issue where the AIC may fail to detect an Impella pump when connected. This pump detection issue can occur during console-to-console transfer or at the start of a case. Critically, the AIC screen does not display a visual alarm to indicate this detection problem.

Also Read: Johnson & Johnson’s Abiomed Unit Recalls Instructions For Some Impella Blood Pumps Due To Cutting Risks

Abiomed has advised users to be vigilant for specific signs. If the screen freezes for more than 20 seconds after ...