Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Cont
FDA device recall Z-2568-2025 · posted 2025-09-19 · Open, Classified
Recall details
- Recalling firm
- Abiomed, Inc.
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- OZD
- Quantity affected
- 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.
- Date initiated
- 2025-08-20
- Date posted
- 2025-09-19
- Location
- Danvers, MA
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