FDA warns that certain Impella heart pump controllers may need serviced
The U.S. Food and Drug Administration (FDA) has shared an early alert about a new safety issue with certain Impella Automated Impella Controllers (AICs) from Johnson & Johnson MedTech.
Devices included in this alert should be removed from where they are used or sold so they can be serviced by Johnson & Johnson MedTech. While awaiting service, however, the AICs can still be used as necessary to ensure patients can still undergo treatment.
This new announcement covers three devices in total:
- Impella Controller, Packaged, US – 0042-0000-US
- Impella Optical Controller, Packaged, US – 0042-000010-US
- Optical, AIC, Impella Controller, Packaged, US – 0042-0040-US
Customers can click here for a list of all serial numbers included in this alert as well as information on how to locate the serial number.
What is the reason for this new alert?
After a retrospective review of servicing records, Johnson & Johnson MedTech determined that certain AICs require hardware, firmware and/or software updates to address various safety concerns. There is a possibility of the AIC failing to recognize the purge cassette during setup, for example. There is also a risk of a “sticking, unreliable button” that could make it harder for the operator to use the device during patient care.
No serious injuries or deaths have been linked to these updates. However, Johnson & Johnson MedTech wanted to act fast to minimize the risk of any future incidents.
“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,” according to the FDA’s advisory.
Click here for more from the FDA.
Johnson & Johnson shares a statement
“Our commitment to quality, safety, and reliability is the foundation of everything we do at Johnson & Johnson,” a spokesperson told Cardiovascular Business. “Working closely with the FDA, we conducted retrospective reviews to implement quality system improvements for AIC. This includes a voluntary medical device recall of certain AICs after identifying some units require specific hardware and/or software updates.
“To ensure continuity of care, with existing alarms, monitoring and mitigation actions, hospital inventory can continue to be used as we work directly with affected customers to implement the necessary updates.”
A recent history of recalls for the Impella platform
Johnson & Johnson MedTech’s Impella devices have been associated with multiple recalls and safety alerts in recent years. In the last several months alone, AIC issues were linked to one recall in July 2025, a second recall in September 2025, third and fourth recalls in October 2025, a fifth recall in December 2025 a sixth recall in May and a seventh recall in August.
In April, the FDA announced a separate recall related to a risk of purge cassettes leaking. Approximately two months later, the agency warned that certain 14 French low-profile introducer kits were recalled due to a risk of thrombus formation. In August, meanwhile, certain introducer sheaths used with Impella devices were recalled due to a risk of leaking.
Johnson & Johnson acquired Abiomed in 2022
The Impella line of heart pumps was previously sold under the Abiomed brand before Johnson & Johnson acquired Abiomed in 2022 for approximately $16.6 billion. In 2024, Abiomed started operating under the name Johnson & Johnson MedTech.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.