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

FDA Recall #Z-2568-2025 — Class I — August 20, 2025

Recall #Z-2568-2025 Date: August 20, 2025 Classification: Class I Status: Ongoing

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.

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.

Recalling Firm

Abiomed, Inc. — Danvers, MA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product 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.

Code Information

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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