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Early Alert: Heart Pump Controller Issue from Abiomed
The FDA is aware that Abiomed has issued a letter to affected customers recommending all Automated Impella Controllers be removed from where they are used or sold.
Abiomed is removing Automated Impella Controllers (“AICs”) due to purge cassette recognition issues resulting from failures of the purge flag component within the purge pressure sensor assembly. The purge flag engages with the purge disc and allows the AIC to recognize that the purge disc is inserted properly.
Exposure to these AIC purge flag component failures requires an AIC exchange to solve the issue. If the failure occurs before support is started, there may be a delay to the procedure. In cases involving hemodynamic instability, this delay may result in a prolonged period without mechanical circulatory support.
If the failure occurs during active Impella support, it will usually occur during an elective exchange of the purge cassette, but may also happen during ongoing support. In the case of ongoing support, mechanical circulatory support will continue while purge delivery is stopped and the AIC exchange is planned. While urgent, exchange of the AIC can be prepared for, including additional hemodynamic stabilization of the patient for the brief interruption of support.
As of August 17, Abiomed has reported 37 serious injuries and three deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public 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 issue should contact Abiomed at (978) 646-1400 or OneMD-Field-Actions@its.jnj.com.
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