The FDA alerted providers that Abiomed issued updated instructions for use related to all of its Automated Impella Controllers (AICs).
This notice comes as part of the FDA’s Communications Pilot to Enhance the Medical Device Recall Program. The FDA issues these warnings when it becomes aware of a high-risk issue. According to a notice, this issue may lead to serious injury or death. As of June 13, Abiomed, a J&J MedTech unit, reports no serious injuries and 3 deaths associated with this issue.
The AIC is the primary user control interface for the Impella catheter, comprising a key component of the Impella heart assist system. Impella provides temporary full or partial heart support, pumping part or all of the patient’s blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the heart to give it time to recover from an acute condition.
Abiomed warned customers that the AIC may not detect an Impella heart pump when connected. Users should keep a backup AIC available in the event of a device failure.
The pump detection issue may occur with any of the Impella pumps and may occur during console-to-console transfer or case start. No visual alarm displays on the AIC screen to indicate the detection issue in these situations. The issue may result in inadequate hemodynamic support. Patients in cardiogenic shock are at increased risk, as prolonged episodes of inadequate support may not be well tolerated. They may lead to life-threatening injuries.
Updated Abiomed instructions
On June 23, Abiomed sent its notice recommending that customers have a back-up AIC available.
When the issue arises, users may see an AIC screen display during console-to-console transfer that remains for more than 20 seconds and doesn’t advance, even after connecting to the transferred console. If the issue occurs, users should immediately switch the pump to the previous console to restore support to the patient.
Additionally, if the previous console displays an alarm message, switch to a different console if available. Users should restart the console that fails to advance from the initial screen before attempting to reconnect to a pump.
Another screen may appear, instructing users to connect the pump. If that image remains for more than 20 seconds after connecting the pump and fails to progress to indicate “Detecting Impella,” users should either re-start the case on the console or switch to a different console.
This marks another recall related to the Impella pumps. Abiomed reported a recall last year that included 49 related deaths. Another version of the pump previously had a Class I recall in 2023 as well. The company earlier this year had a separate update to the instructions for use as well.
