Abiomed identified purge cassette recognition issues “resulting from failures of the purge flag component within the purge pressure sensor assembly.” J&J issued the voluntary recall of its AICs after identifying the issue in 0.2% of cases, a J&J spokesperson told MassDevice.
J&J said “hospital inventory can continue to be used to ensure continuity of care” while awaiting replacement. The company told customers to reinsert the purge disc to address an alarm that occurs if there’s component failure; if that doesn’t work, Abiomed recommended switching to a backup Automated Impella Controller.
“Patient safety remains our top priority, and existing alarms and monitoring support the safe and effective use of Impella,” the J&J spokesperson said.
The reason for the alert
Impella reduces the work of the heart’s left ventricle, providing support for a patient’s circulatory system so the heart can recover. The AIC is the main user control interface for Abiomed’s Impella catheter. It controls catheter performance, monitors for alarms and provides information about the catheter’s location across the aortic valve.
“Exposure to these AIC purge flag component failures requires an AIC exchange to solve the issue,” the FDA early alert said. “If the failure occurs before [hemodynamic] support is started, there may be a delay to the procedure. In cases involving hemodynamic instability, this delay may result in a prolonged period without mechanical circulatory support.”
Abiomed said it’s replacing the purge flag and purge retainer components in the purge pressure sensor assembly of the AIC to resolve the issue in affected devices. The replacement will occur through annual preventative maintenance or outreach from Abiomed’s service team, the company said.
The latest warning for Abiomed and Impella
Since J&J acquired Abiomed for $16.6 billion in 2022, the company has faced numerous regulatory issues with the Impella platform. In 2026 alone, Abiomed has faced at least five different regulatory issues with the Impella platform.
Most recently, in May 2026, J&J recommended that customers remove certain Impella CP sets with SmartAssist that didn’t meet design specifications, potentially causing low purge pressure events leading to the interruption or loss of mechanical circulatory support. As of May 7, Abiomed reported three pump exchanges and one death associated with the issue.
In the middle of May, Abiomed initiated a voluntary recall of its Impella AICs after identifying a “potential software issue in a limited number of Automated Impella Controllers (AICs) when used with left ventricular Impella devices,” the company said at the time.
Abiomed said it’s working on a software update to address the issue, according to the FDA Class I recall webpage last updated on June 22. The company reported two serious injuries and one death associated with this issue as of April 27.
In February 2026, Abiomed issued an urgent medical device correction, notifying affected customers of updated use instructions for all Impella RP with Smart Assist and Impella RP Flex with Smart Assist devices. The company identified that a sensor in Impella RP systems may malfunction and could potentially drift and display inaccurate information. Abiomed reported 22 serious injuries associated with this issue as of January 15.
In that same month, the company recommended customers remove certain Impella Purge Cassettes and Impella RP Pump sets after identifying that first-generation purge cassettes faced an increased risk of purge leaks. Abiomed reported four serious injuries associated with this issue as of Febuary 3.
