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Early Alert: Blood Pump Controller Issue from Abiomed

The FDA is aware that Abiomed has issued a letter to affected customers recommending all Automated Impella Controllers (AIC) have updated instructions for use. Abiomed has identified an issue with the AIC that may impair the detection of an Impella pump when connected to an AIC. There is no visual alarm displayed on the AIC screen to indicate the detection issue.

This issue may result in inadequate hemodynamic support. Patients in cardiogenic shock are at increased risk, as prolonged episodes of inadequate support may not be well tolerated and may lead to life-threatening injuries.

At this time, Abiomed has reported three deaths 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 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 978-646-1400.