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Early Alert: Heart Pump Purge Cassette Issue from Abiomed
The FDA is aware that Abiomed, Inc. has reported an increased risk of purge leaks in Generation 1 Purge Cassettes. As a result, Abiomed is removing Generation 1 Purge Cassettes in markets where updated Generation 2 Purge Cassettes are available.
If a Purge Cassette leak were to occur, the user would see a “Purge Pressure Low” alarm on the Automated Impella Controller. A purge leak may lead to low purge pressure if it goes unaddressed. This can lead to biomaterial ingress, which may lead to an unexpected pump stop. A pump stop may result in a loss of hemodynamic support and lead to patient death.
As of February 3, Abiomed has reported four serious injuries and no 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 OneMD-Field-Actions@its.jnj.com.
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