Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.
FDA Recall Z-2568-2025 · Posted 2025-09-19
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Recalling FirmAbiomed, Inc.
Recall StatusOpen, Classified
Product CodeOZD
Date Initiated2025-08-20
Product Quantity71 units
Reason for Recall
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
Firm Action
Abiomed notified consignees via letter on about 08/20/2025. Consignees were instructed to quarantine and cease use of all affected units, contact Abiomed Field Service team to initiate the remediation process, complete and return the business reply form with the assistance of your Abiomed Representative, forward the recall notification to any applicable personnel and notify customers if affected units were further distributed or transferred. Abiomed also posted a version of the recall notification letter on their website.
Root Cause
Device Design
Distribution Pattern
US distribution to AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH, PA, TX. International distribution to Canada, Germany, Great Britian, Italy, Netherlands, Norway.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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