Johnson & Johnson's Abiomed unit is removing every Automated Impella Controller worldwide to replace parts linked to failures that have been associated with 37 serious injuries and three deaths, according to the FDA's early alert. Hospitals may keep using their controllers while they wait for service.
The controllers run Impella heart pumps, which temporarily take over part of the heart's pumping work in critically ill patients, including people in cardiogenic shock and those undergoing high-risk heart procedures. The affected U.S. products are the Impella Controller, the Impella Optical Controller, and the Optical Automated Impella Controller packages.
The FDA issued the alert on Aug. 26 and updated it on Sept. 3. In that update, the agency said it was still reviewing the issue. An FDA early alert is a preliminary public notice about a potentially high-risk device problem, issued before the agency completes its review and assigns a final recall classification.
What Fails Inside the Controller
The problem involves a small component called the purge flag, which helps the controller recognize that a fluid disc is inserted correctly. If it fails while a procedure is being set up, the controller displays a "Purge Disc Disconnected" alarm. If it fails while the pump is supporting a patient, the alarm reads "Purge Disc not Detected."
In either case, the FDA said staff should first reinsert the purge disc and, if the alarm does not clear, switch to a backup controller. A failure before support begins can delay a procedure, and in patients with unstable blood pressure and circulation, that delay may mean a longer period without mechanical heart support. If the failure happens during ongoing support, the pump keeps working while fluid delivery is paused and staff prepare to exchange the controller.
"Johnson & Johnson has issued a voluntary recall of Automated Impella Controllers to address a purge cassette recognition issue identified in 0.2% of cases," a company spokesperson told Cardiovascular Business. "Hospital inventory can continue to be used to ensure continuity of care."
The removal is global and phased. Abiomed's field service team is contacting hospitals to replace the purge flag and purge retainer components, either during annual preventive maintenance or through individual outreach. The company also told customers that improper cleaning can damage plastic parts, including the purge flag, and that controller housings should be cleaned with mild detergent as the instructions specify.
Questions Families Can Ask the Care Team
Most readers will never see an Impella controller. The people affected are patients in intensive care units and cardiac catheterization labs, along with the spouses, adult children, and caregivers helping make decisions on their behalf.
Families of patients who are on, or may need, Impella support can reasonably ask whether their hospital has received the manufacturer's notice, whether a backup controller is immediately available, and how staff are trained to respond to these specific alarms. Treatment decisions should stay with the medical team, and no one should delay urgent cardiac care because of this action.
The controller is a bedside console used inside the hospital, so the removal involves hospital equipment rather than anything patients take home. Anyone with questions about past treatment can ask their cardiologist.
Patients and clinicians can report device problems to FDA MedWatch. U.S. customers with device questions can contact Abiomed at (978) 646-1400.
A Long String of Impella Safety Actions
This is not an isolated event. Automated Impella Controller issues have been linked to multiple recalls since July 2025, involving problems such as controllers failing to detect a connected pump, underrated electrical parts, cracked purge retainers, cybersecurity vulnerabilities, and a software error that can force a restart, according to MedTech Dive and FDA notices. Impella introducer kits also received the FDA's most serious recall classification this summer, as MedicalDaily reported in August.
Johnson & Johnson acquired Abiomed in 2022 for about $16.6 billion. In September 2023, the company received an FDA warning letter over quality problems with the devices.
Still unknown is how quickly every controller will be serviced, whether the FDA will assign a final recall classification, and whether additional incidents have been reported since mid-August. MedicalDaily will monitor FDA updates and any revised injury counts.
Developing Story Timeline
Aug. 12, 2026: Abiomed sent affected customers a letter with alarm-response steps and replacement plans.
Aug. 17, 2026: Abiomed's reported total reached 37 serious injuries and three deaths associated with the issue.
Aug. 26, 2026: The FDA issued an early alert saying all Automated Impella Controllers should be removed from where they are used or sold, with hospital inventory allowed to remain in use.
Sept. 3, 2026: The FDA updated its early alert page and said it was still reviewing the issue.
Key Questions Answered
What is happening with Impella controllers? Abiomed is removing all Automated Impella Controllers worldwide in phases to replace purge flag and purge retainer components linked to alarm failures.
Which devices are affected? The Impella Controller, Impella Optical Controller, and Optical Automated Impella Controller packages sold in the U.S.
Are hospitals still using these controllers? Yes. The FDA and the company say hospital inventory can continue to be used while replacements are scheduled, with backup controllers available.
How many injuries and deaths have been reported? Abiomed reported 37 serious injuries and three deaths associated with the issue as of Aug. 17, 2026.
How can problems be reported? Through FDA MedWatch, or by contacting Abiomed at (978) 646-1400.
