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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
The FDA is aware that Abiomed has sent all affected customers a letter regarding a purge retainer fixation issue with the Automated Impella Controller. Abiomed has found that the force users apply during purge disc insertion/removal contributes to the purge retainer failures, which may lead to errors, alarms, and potential interruptions in hemodynamic support. Loss of hemodynamic support poses a serious risk to patient health and may lead to permanent impairment or death.
As of August 27, Abiomed has reported five serious injuries and no deaths 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 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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