Another Issue Shelves Some Impella Blood Pump Controllers: FDA

Certain Automated Impella Controllers (AICs), the main control interface for the Impella catheter (Abiomed/Johnson & Johnson MedTech), should not be used after another issue potentially affecting pump performance has been identified, according to an alert today from the US Food and Drug Administration. The news comes on the heels of a separate announcement, in early July, that also pertained to the AICs of the mechanical circulatory support device.

Last week, Abiomed sent customers a letter that recommended removing from use and quarantining controllers with the following product codes: 0042-0000-US, 0042-0000-EU, 0042-0000-UK, 0042-0000-CA.

This issue affects 69 AIC units globally, or 0.68% of controllers distributed as of July 29, 2025. A spokesperson for the company said it will provide loaner controllers for its customers.

The company said the affected controllers have a pump driver circuit assembly that doesn’t meet current specifications due to incorrect capacitors. This “may lead to decreased pump performance or pump stop and trigger an ‘Impella Failure’ or ‘Impella Stopped. Controller Failure’ alarm,” according to the FDA. The problem could ultimately result in “transient hemodynamic instability, loss of circulatory support, or death.”

As of August 12, Abiomed reported one death and no other serious injuries tied to the issue, which had an occurrence rate of 0.006% (27 complaints out of 393,776 uses between January 2011 and June 2025).

This problem comes just a month after the FDA warned of another issue with the AICs that had the potential to affect the detection of the Impella pumps when connected to the controllers. The fix was an update to the instructions for use and no devices were removed from use. That issue was tied to three deaths, and no additional serious injuries, as of June 13.