Sam Brusco, Associate Editor06.05.23
The U.S. Food and Drug Administration (FDA) has deemed Abiomed’s April 17 recall of specific Impella 5.5 with SmartAssist sets as Class I.
The system is used for up to two weeks to support the heart ventricles when there’s ongoing cardiogenic shock that happens under 48 hours after a severe heart attack, open-heart surgery, or when the heart isn’t functioning well due to cardiomyopathy.
Abiomed recalled the devices after receiving customer complaints about purge fluid leaking from the pump’s purge sidearm. If a purge leak occurs, the system will experience low purge pressure that prompt alarms and require evaluation. If the leak issue isn’t resolved, persistent low purge pressure and purge flow can cause pump stop and loss of therapy.
In critical patients, failure of pump support can lead to further deterioration and worsening of an already critical condition, potentially even leading to serious injury or death.
Abiomed has reported 179 complaints, three injuries, and no deaths related to this recall. Further information is available on the FDA website.
The system is used for up to two weeks to support the heart ventricles when there’s ongoing cardiogenic shock that happens under 48 hours after a severe heart attack, open-heart surgery, or when the heart isn’t functioning well due to cardiomyopathy.
Abiomed recalled the devices after receiving customer complaints about purge fluid leaking from the pump’s purge sidearm. If a purge leak occurs, the system will experience low purge pressure that prompt alarms and require evaluation. If the leak issue isn’t resolved, persistent low purge pressure and purge flow can cause pump stop and loss of therapy.
In critical patients, failure of pump support can lead to further deterioration and worsening of an already critical condition, potentially even leading to serious injury or death.
Abiomed has reported 179 complaints, three injuries, and no deaths related to this recall. Further information is available on the FDA website.