device · product 1 of 1
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.
- Recall number
- Z-1591-2026
- Initiated
- February 16, 2026
- Classification
- Class I
- Status
- Ongoing
- Recalling firm
- Abiomed, Inc.
- Quantity
- 62 units
App-derived interpretation
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
Official device-enrichment evidence · Sourced
Software design
Inspect official wording and provenance
Reason for recall
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
Code information
All products below with software version 8.2.2 through 8.5 are affected. 1. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC2035, IC9416. 2. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581. 3. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312. 4. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC1140. 5. Product Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683. 6. Product Code: 0042-0010-UK; GTIN: 00813502010978; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440. 7. Product Code: 0042-0040-CA; GTIN: 00813502012958; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894. 8. Product Code: 0042-0040-EU; GTIN: 00813502012217; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425. 9. Product Code: 0042-0040-AU; GTIN: 00813502012972; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151.
Distribution pattern
International distribution in the country of Australia, Canada, France, Germany, Kuwait.