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Early Alert: Automated Impella Controller Issue from Abiomed
The FDA is aware that Abiomed has sent all affected customers a letter recommending certain Automated Impella Controllers be removed from where they are used or sold as these devices may have a Pump Driver Circuit Assembly that does not meet current specifications.
The Pump Driver Circuit Assemblies contain 25v-rated tantalum capacitors instead of 35-v rated tantalum capacitors, which may lead to decreased pump performance or pump stop and trigger an “Impella Faliure” or “Impella Stopped. Controller Failure.” alarm. In the case of capacitor failure in the Automated Impella Controller, an abrupt pump stoppage or decreased performance of the Automated Impella Controller may occur, potentially resulting in transient hemodynamic instability, loss of circulatory support, or death.
As of August 12, Abiomed has reported one death and no serious injuries associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abiomed at ra-abm-fieldaction@its.jnj.com.
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