Abiomed, Inc.: Device Recall
Recall #Z-2568-2025 · 08/20/2025
Recall Details
- Recall Number
- Z-2568-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Abiomed, Inc.
- Status
- Ongoing
- Date Initiated
- 08/20/2025
- Location
- Danvers, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 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.
Product Description
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.
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.
Other Recalls by Abiomed, Inc.
- Class II: Risk 12/04/2025
- Class I: Dangerous 10/01/2025
- Class I: Dangerous 09/16/2025
- Class I: Dangerous 06/23/2025
- Class I: Dangerous 12/12/2024