Abiomed recalled 62 Automated Impella Controller units sold to hospitals internationally. The recall warns of a delayed Purge System Blocked alarm display when used with first generation Impella 5.5 pumps. Hospitals should stop using the device immediately and contact Abiomed for instructions.
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The Impella Controller is part of a heart support system used in hospitals with the Impella 5.5 pump. It manages and displays purge and pump status.
Delay in alarm display could hinder timely response to purge-system issues, potentially affecting patient safety.
This recall is not described as part of a broader industry pattern.
Hospitals must pause use until the device is replaced or updated; potential workflow disruption and patient risk if alarms are not promptly displayed.
FDA recall page and Abiomed support channels. Timeline and remedy details issued by Abiomed.
4-8 weeks for remediation actions typical in recalls.
Keep copies of the recall notice, emails from Abiomed, and any correspondence with clinicians.
- Product Code: 0042-0000-CA; Impella Controller, Packaged, CA; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0000-EU; Impella Controller, Packaged, EU; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0000-UK; Impella Controller, Packaged, UK; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0000-US; Impella Controller, Packaged, US; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0010-EU; Impella Optical Controller, Packaged, EU; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-?
No injuries or incidents have been reported.
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