Abiomed recalls Automated Impella Controllers with software versions 8.2.2-8.5 that may delay 'Purge System Blocked' alarms when used with first-gen Impella 5.5 pumps. Affected units include specific product codes and serial numbers.
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.
Abiomed is recalling Automated Impella Controllers with software versions 8.2.2 through 8.5 that could delay the 'Purge System Blocked' alarm when used with first-generation Impella 5.5 pumps. This delay might lead to improper pump function during medical procedures.
The 'Purge System Blocked' alarm on the controller might delay triggering when the pump is used with older Impella 5.5 models. This could lead to improper pump function during medical procedures if the alarm isn't activated in time.
Healthcare professionals using the Automated Impella Controller with first-generation Impella 5.5 pumps are most at risk. Patients receiving treatment with these specific devices may be affected if the alarm delay causes improper pump operation.
Check for product codes starting with 0042-0000 or 0042-0010 with software versions 8.2.2 through 8.5. Affected units include specific serial numbers listed in the recall notice for each region.
Verify the software version on your Automated Impella Controller; versions 8.2.2 through 8.5 are affected.
The recall occurs because the 'Purge System Blocked' alarm may delay triggering when the Automated Impella Controller is used with first-generation Impella 5.5 pumps, potentially leading to improper pump function.
Affected models include Automated Impella Controllers with product codes starting with 0042-0000 or 0042-0010 and software versions 8.2.2 through 8.5, as listed in the recall notice.
You should check your software version; if it's 8.2.2 through 8.5, contact Abiomed for guidance on next steps.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-1591-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-1591-2026 from Abiomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
