Recall Z-2568-2025 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
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 Contro
| Date | Sep 19, 2025 (initiated Aug 20, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 71 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.