FDA Classifies Abiomed's Removal of All Automated Impella Controllers as Class I Recall

The Food and Drug Administration has classified Abiomed's removal of its Automated Impella Controllers, the console that runs Impella heart pumps, as a Class I recall, according to an update the agency posted on September 24.

The FDA notice says Abiomed, part of Johnson & Johnson MedTech, has recommended that all Automated Impella Controllers be removed from where they are used or sold. The FDA had earlier issued an early alert on the issue. The recall covers three packaged controller products, including optical versions, and Abiomed says all units globally are in scope, so it is taking a phased approach.

The reported failure

Abiomed said it is removing the controllers because of purge cassette recognition issues caused by failures of the purge flag, a component within the purge pressure sensor assembly that lets the controller recognize that the purge disc is properly inserted.

If the failure occurs while a procedure is being set up, the controller shows a "Purge Disc Disconnected" alarm; during heart pump support, it shows a "Purge Disc not Detected" alarm, according to the notice. Abiomed said the failure requires a controller exchange. Before support begins, that may delay the procedure, and in patients with unstable hemodynamics the delay may mean a longer period without mechanical circulatory support. If it happens during support, mechanical circulatory support continues while purge delivery stops and the exchange is planned, the company said.

As of August 17, Abiomed had reported 37 serious injuries and three deaths associated with the issue, the FDA said.

What Abiomed told customers

In an August 12 letter, Abiomed told customers to first reinsert the purge disc when the alarm appears and, if that does not clear it, to switch to a backup controller. The letter said improper cleaning can damage plastic components including the purge flag, and asked customers to clean the controller housing with mild detergent as the instructions specify and to keep up annual preventive maintenance. The FDA notice says hospital inventory can continue to be used while awaiting service from Abiomed to ensure continuity of care.

Abiomed is replacing the purge flag and purge retainer components through annual preventive maintenance or individual outreach by its service team, according to the notice.

A J&J spokesperson told MedTech Dive that the purge cassette recognition issue was identified in 0.2% of cases, and said, "Patient safety remains our top priority, and existing alarms and monitoring support the safe and effective use of Impella." MedTech Dive reported that the removal is the latest in a series of issues affecting Impella systems since J&J acquired Abiomed for $16.6 billion in 2022, and that the FDA sent J&J a warning letter over quality problems with the devices in September 2023.

According to the FDA, the Automated Impella Controller is the primary user control interface for the Impella catheter: it controls the catheter's performance, monitors it for alarms and provides information on the catheter's position across the aortic valve. Impella pumps provide mechanical circulatory support during certain procedures or when the heart cannot pump enough blood on its own, MedTech Dive noted.