Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co
Summary
The FDA issued a Class I for Automated Impella Controller (AIC) with the below brands and product codes. Used by Abiomed, Inc.. Reason: Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased .
Details
Source
Device Recall
External ID
Z-2568-2025
Action Date
2025-10-01
Status
Ongoing
Category
device
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.
Lot/Code Info: 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.
Quantity Affected: 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-20
Company
Danvers, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 152 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abiomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abiomed, Inc. have FDA actions?
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2568-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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