Abiomed, Inc. is recalling 62 units of the Automated Impella Controller (AIC) because the "Purge System Blocked" alarm may be delayed when used with first-generation Impella 5.5 pumps. The controllers affected are running software versions 8.2.2 through 8.5. This delay can prevent medical staff from identifying and addressing a blockage in the pump's purge system, which is critical for maintaining the device's function.
A delay in the "Purge System Blocked" alarm can lead to pump failure or damage, which may cause serious health consequences including loss of circulatory support, organ damage, or death in patients who are dependent on the device.
Used specifically with first generation Impella 5.5 (0550-0008*) pumps.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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