Z-2568-2025Class I

Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1...

Name: Z-2568-2025 Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1...
Creator: Abiomed, Inc.
Published: 2025-08-20
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2025-08-20 / Open, Classified / root cause: design

FDA source

Abiomed, Inc. began a recall of Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code... on 2025-08-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2568-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-08-20
Posted: 2025-09-19
Recalling firm: Abiomed, Inc.
Product: 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.
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 1. Product Code: 0042-0000-US; GTIN: 813502010022; Serial Numbers: IC1026, IC1029, IC1043, IC1046, IC1040, IC1047, IC1088, IC1089, IC1093, IC1110, IC1167, IC1221, IC1225, IC1222, IC1258, IC1250, IC1272, IC1293, IC1320, IC1317, IC1353, IC1354, IC1355, IC1375, IC1377, IC1403, IC1446, IC1450, IC1452, IC1461, IC1496, IC1501, IC1508, IC1515, IC1516, IC1517, IC1518, IC1530, IC1534, IC1535, IC1539, IC1538, IC1531, IC1533, IC1540, IC1532, IC1551, IC1552, IC1550, IC1553, IC1646, IC1756, IC2255, IC2422, IC2489, IC3013. 2. Product Code: 0042-0000-US-L; GTIN: 813502010022; Serial Number: IC1281. 3. Product Code: 0042-0000-CA; GTIN: 813502011272; Serial Numbers: IC1543, IC1544. 4. Product Code: 0042-0000-EU; GTIN: 813502011289; Serial Numbers: IC1350, IC1383, IC1546, IC1548, IC1547, IC1549, IC1775, IC2243, IC4002. 5. Product Code: 0042-0000-UK; GTIN: 813502011296; Serial Numbers: IC1519, IC1542. 6. Product Code: 0042-0000-UK-L; GTIN: 813502011296; Serial Number: IC1493.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2568-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2568-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19

Product code OZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)