Abiomed Automated Impella Controller
Abiomed is recalling 30+ models of Impella Controllers due to a software error that may affect left ventricular support devices.
Healthcare providers should review the manufacturer's urgent medical device correction notice for specific software update instructions and operational guidance. Contact Abiomed for further technical support.
Why it was recalled
Abiomed is recalling 30+ variants of the Automated Impella Controller and Impella Optical Controller used with left ventricular support devices due to a potential software error. The full list of affected product codes is available on the FDA recall page.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella C | 00813502010886, 00813502011272, 00813502011289, 00813502010930, 00813502010961, 00813502011425, 00813502010978, 00813502010985, 00813502012958, 00813502012217, 00813502011814, 00813502012972, 00813502012484, 00813502011401 | Z-2360-2026 |
| Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes | – | – |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Abiomed, Inc.
Editorial summary by Recall Canary · last updated 2026-06-13 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification