Abiomed identified quality issues, including purge cassette recognition failures and unreliable buttons, that could delay therapy or cause loss of hemodynamic support.

The FDA has issued an early alert regarding a potentially high-risk device issue involving Abiomed’s Automated Impella Controller (AIC), the primary user interface for the company’s Impella heart pump catheters.

Abiomed sent affected customers a letter on Sept 18, 2026, recommending that certain Automated Impella Controllers be removed from where they are used or sold. However, the FDA notes that hospital inventory can continue to be used while awaiting service from Abiomed to ensure continuity of care.

The affected devices include the Impella Controller, Packaged, US (product number 0042-0000-US); the Impella Optical Controller, Packaged, US (0042-0010-US); and the Optical, AIC, Impella Controller, Packaged US (0042-0040-US). The alert applies to a limited set of specific consoles identified by serial number.

Reason for the Alert

Abiomed stated that a retrospective review of servicing records identified certain Impella Controllers that require hardware, firmware, and/or software updates to address quality issues with the potential for safety implications.

According to the FDA, the identified quality issues include:

  • A potential failure of the AIC to recognize the purge cassette during setup or change.
  • A sticking, unreliable button that could impact the operator’s ability to select and confirm menu entries and possible loss of control of the console.
  • An instability that could result in start-up failure.
  • Other software defects.

Without the hardware, firmware, and/or software updates, patients could face various problems such as delay of therapy, inadequate or loss of hemodynamic result, and other serious issues, the FDA says.

As of Sept 8, 2026, Abiomed has reported no serious injuries or deaths associated with this issue.

The FDA notes that various hardware, firmware, and/or software updates are available but have not been implemented consistently across all potentially impacted units. Abiomed is directing customers to take the following steps:

  • Continue using hospital inventory while awaiting service from Abiomed to ensure continuity of care.
  • Expect contact from the Abiomed service team to coordinate the removal, update, and return of affected devices.
  • Forward the notice to anyone in the facility who manages, transports, stores, stocks, or uses the subject products.
  • Contact any facility that received forwarded product and share the notice.
  • The serial number of the AIC is located on the label on the right side of the device.

Device Use and Reporting

The Automated Impella Controller controls the Impella Catheter and monitors the catheter for alarms. Impella therapy aims to reduce the work of the heart and provide circulatory support so the heart has time to recover.

Customers in the US with adverse reactions, quality problems, or questions about this issue—or if the serial number is missing or illegible—should contact the Abiomed Field Service Team at 1-800-422-8666, option 3, or email [email protected].

Healthcare professionals and consumers may report adverse reactions or quality problems through MedWatch, the FDA’s safety information and adverse event reporting program. The FDA says it is currently reviewing information about the issue and will keep the public informed as significant new information becomes available.