Reported Apr 8, 2026 · Ongoing
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes
9 of 9 products
| Model / number | Product as published |
|---|---|
0042-0000-CA. | Impella Controller, Packaged, CA |
0042-0000-EU. | Impella Controller, Packaged, EU |
0042-0000-UK. | Impella Controller, Packaged, UK |
0042-0000-US. | Impella Controller, Packaged, US |
0042-0010-EU. | Impella Optical Controller, Packaged, EU |
0042-0010-UK. | Impella Optical Controller, Packaged, UK |
0042-0040-CA. | Optical AIC w/Impella Connect, Pack'd, CA |
0042-0040-EU. | Optical AIC w/Impella Connect, Pack'd, EU |
0042-0040-AU. | Optical, AIC, Impella Connect, Pkgd, AU |
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published 00813502011272Product Code: 0042-0000-CA; ; Serial Numbers: IC2035, IC9416. 00813502011289Product Code: 0042-0000-EU; ; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581. 00813502011296Product Code: 0042-0000-UK; ; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312. 00813502010022Product Code: 0042-0000-US; ; Serial Numbers: IC1140. 00813502010961Product Code: 0042-0010-EU; ; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683. 00813502010978Product Code: 0042-0010-UK; ; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440. 00813502012958Product Code: 0042-0040-CA; ; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894. 00813502012217Product Code: 0042-0040-EU; ; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425. 00813502012972Product Code: 0042-0040-AU; ; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151. - Amount recalled
- 62 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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