Dive Brief:
- Johnson & Johnson has advised customers to remove automated Impella heart pump controllers from where they are used or sold due to component failures tied to three deaths and 37 serious injuries, the Food and Drug Administration said Wednesday in an early alert. J&J’s Abiomed business is replacing components within the purge pressure sensor assembly of the controllers.
- Hospital inventory can still be used while awaiting service from Abiomed to ensure continuity of care. “Patient safety remains our top priority, and existing alarms and monitoring support the safe and effective use of Impella,” a J&J spokesperson said in an email to MedTech Dive.
- The removal is the latest in a string of issues that have affected Impella systems, including the automated controllers, since J&J bought Abiomed for $16.6 billion in 2022. In September 2023, J&J received a warning letter from the FDA over quality problems with the devices.
Dive Insight:
Impella pumps are implanted to provide mechanical circulatory support for patients during certain procedures or when the heart cannot pump enough blood on its own.
J&J has said that as part of its integration of the Abiomed business, it conducted comprehensive, retrospective audits of its quality system and processes that resulted in field actions. Those actions show the company’s processes are rigorous and working as intended, J&J said in May.
The automated controller is the primary user control interface for the Impella catheter. It controls the catheter’s performance, monitors for alarms and provides information on the device’s location across the aortic valve.
The latest recall addresses a purge cassette recognition issue identified in 0.2% of cases, the spokesperson said.
In an Aug. 12 letter, J&J told customers that if an alarm indicates a purge flag component failure, they should first reinsert the purge disc. If that does not clear the alarm, they should switch to a backup automated Impella controller.
Customers should work with the Abiomed field service team to schedule replacement of the purge flag and purge retainer components within the unit’s purge pressure sensor assembly.
