Missing Hardware Updates on 91 Impella Consoles Draw FDA's Most Serious Recall Rating

The US Food and Drug Administration has identified Abiomed's correction of certain Automated Impella Controllers, the consoles that run its Impella heart pumps, as the most serious type of recall, according to a notice the agency posted on June 11.

The notice says the action involves correcting devices rather than removing them from where they are used or sold, and that the device "may cause serious injury or death if you continue to use it without correction." The affected product is the US-packaged Impella Controller, product code 0042-0000-US. The FDA recall database entry (Z-2211-2026) lists 91 units in commerce, distributed in 14 US states and several other countries, and records the recall as Class 1.

Four hardware updates

According to the FDA, Abiomed identified controllers that require specific hardware updates during a retrospective review of servicing records. The database entry says the updates have been implemented through Abiomed's servicing process, so controllers that have not been serviced are still pending them. The FDA notice lists four issues:

• An internal video cable sitting close to the digital signal processor chipset could allow electrostatic discharge to couple into the processor, which may interrupt motor controls. The fix is a cable retention device.
• A compact flash memory card could be dislodged by external force, which could cause startup failures and data-logging issues. The fix is a card retainer.
• Improper routing of the fan wire could damage the wire and cause console boot-up failure. The fix is a wire clip.
• Capacitors on the power battery manager could cause pump stop, purge stop or single-fan fuse failures. The fix is a new circuit board assembly with improved components.

The FDA said all four issues could lead to a failure to boot the controller or a sudden interruption in hemodynamic support, and in all cases the console would have to be exchanged for a replacement, further delaying treatment. The agency said that "As of April 14, Abiomed has not reported any serious injuries or deaths associated with this issue."

What Abiomed told customers

Abiomed sent affected customers a letter on April 20. The letter said the company's servicing team will contact facilities with affected controllers to arrange their return so the changes can be made, and that hospital inventory can continue to be used to ensure continuity of care. Customers were asked to pass the notice to anyone in their facility who manages or uses the controllers and to any facility the products had been forwarded to.

The Automated Impella Controller is the primary user interface for the Impella catheter. It controls pump performance, monitors for alarms and provides real-time information on the catheter's position across the aortic valve, the FDA said. The database entry lists the cause as under investigation by the firm and the recall as open.