Abiomed is replacing components in Automated Impella Controllers following reports of injuries and deaths linked to purge cassette recognition issues.
The Food and Drug Administration (FDA) issued an early alert regarding a high-risk issue with Abiomed Automated Impella Controllers, which have been linked to 37 serious injuries and three deaths. The alert follows reports of purge cassette recognition issues caused by the failure of a purge flag component within the device’s purge pressure sensor assembly.
The purge flag is designed to engage with the purge disc, allowing the controller to recognize that the disc is correctly inserted. Abiomed is addressing these failures by replacing the purge flag and purge retainer components through a phased removal approach. The company will coordinate these replacements during annual preventive maintenance or through individual outreach by its field service team.
Impact on Clinical Procedures
Failures of the purge flag component can lead to “Purge Disc Disconnected” or “Purge Disc not Detected” alarms. If a failure occurs before a procedure begins, it may cause delays in mechanical circulatory support. During active support, failures often occur during an elective exchange of the purge cassette, requiring an exchange of the controller.
While the exchange is urgent, it can be prepared for by stabilizing the patient for the brief interruption of support, says Abiomed, the device manufacturer, in a release.
Recommendations for Healthcare Facilities
The FDA states that hospital inventory can continue to be used to ensure continuity of care while awaiting service from Abiomed. In the event of an alarm, users are instructed to first reinsert the purge disc. If this does not clear the alarm, staff should switch to a backup Automated Impella Controller.
The company also highlighted that improper cleaning can damage plastic components, including the purge flag. Facilities are advised to clean the controller housing with a mild detergent as specified in the instructions for use, and they should ensure routine preventive maintenance is performed annually.
The Automated Impella Controller is the primary interface for the Impella catheter, controlling performance, monitoring for alarms, and providing position information. Affected products include the Impella Controller and the Impella Optical Controller packaged for use in the US.
