Abiomed flagged a heart pump controller purge cassette problem that has been linked to three patient deaths, according to an Aug. 26 FDA alert.
The company is recommending all Automated Impella Controllers be removed from where they are used or sold, including Impella controller, Impella Optical Controller, and Optical, AIC, Impella Controller. While waiting for replacements from Abiomed, hospitals can continue to use the devices in their inventory.
“Abiomed is addressing these failures by replacing the purge flag and purge retainer components within the purge pressure sensor assembly of the AIC,” the alert said. Implementation of this replacement will be done through annual preventative maintenance or individual outreach by the company’s service team.
To date, 37 serious injuries and three deaths have been associated with the issue.
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