Group of pf young cardiologists with interest in CICU devices
ABIOMED IMPELLA 5.5 PURGE FLUID LEAK, FDA RECALL. APRIL 2023.
*
In April 2023, FDA published a recall about Impella 5.5.
Impella 5.5 is the Impella heart pump with the maximum blood flow.
In case of a purge leak, the system will encounter reduced purge pressures, triggering alarms and necessitating assessment. If the leak problem remains unresolved, continuous low purge pressure and purge flow could result in the pump shutting down, leading to the loss of therapy.
The company advises using water for cleaning. It is essential to avoid using sterilization solutions containing isopropyl alcohol (like ChloraPrep or Hibiclens) on the purge system.
The reason is that isopropyl alcohol could potentially weaken or damage these components of the Impella purge system.