FDA Warns Public About Johnson & Johnson SubsidiaryAbiomedSafety Issues with the Impella Controller (AIC) Manufactured by ABIOMED, Inc.This isImpella Controller Following FDA Warning Last Month (Johnson & Johnson Cardiac Intervention Pump Warned Again by FDA | 3 Deaths), once again warned by the FDA. The previous warning did not involve a product recall, only an update to the instructions. However, this time it's different, Johnson & Johnson has requestedDiscontinue or remove specific models of Impella controllers from the market.Impella Controller:The controller is the primary user control interface for the Impella catheter, used to operate the Impella catheter and monitor catheter alarms. Impella therapy is designed to reduce the workload of the left ventricle, provide support to the circulatory system, and buy time for cardiac recovery.Only Involved69 unitsImpella Controller
Johnson & Johnson Discovery: The pump drive circuit components of specific Impella controllers do not meet current specification requirements. These components use capacitors rated at 25V instead of the specified 35V, which may lead to decreased pump performance or pump shutdown, triggering "Impella Fault" or "Impella Stopped, Controller Fault" alarms (see figure below).
Impella Malfunction: Replacement of Impella Device
Impella Stop, Controller Failure: Switch to Backup Controller
If the capacitor in the Impella controller fails, it may lead to sudden pump stop or decreased controller performance, potentially causing transient hemodynamic instability, failure of circulatory support, or death.
As of August 12, Johnson & Johnson has reported one death and no serious injury events.
Johnson & Johnson's Preliminary Solutions
Please stop using the affected products immediately. Identify and isolate all affected devices.Johnson & Johnson StatementA review of complaint records from January 2011 to June 2025 shows that the issue occurred at a rate of 0.006%, with one complaint reporting patient death. Patient safety is our top priority, and we are deeply committed to ensuring the safety and quality of our technology. Affected customers were notified starting August 21, 2025, and a backup will be provided.Impella ControllerFor customer use.
