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Impella Heart Pump Software Recall
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MEDICAL DEVICE RECALLCRITICAL

Impella Heart Pump Software Recall

Abbott's Impella heart pumps may fail to restart after certain operational faults, posing a serious health risk to patients.

What to do

Contact Abiomed's patient support team or your clinician immediately. Review the FDA recall notice for instructions regarding controller updates and any need to return the device.

Recalled
Listed
Updated
Recall No.
Z-2360-2026
Agency
FDA
Firm
Abiomed, Inc.
Recall ID
98853
Status
ONGOING

Recall at a glance

Quantity recalled
10,297 units

Why it was recalled

Abbott's Impella heart pumps may fail to restart after certain operational faults, posing a serious health risk to patients. Impella 5.5 and Impella 5.5 with SmartAssist devices are affected. A ICD-10-PCS code issue could lead to controller downtime that may require the pump to be restarted or replaced.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeUDI-DI
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
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled asAll products below with software versions 600813502010886, 00813502011272, 00813502011289, 00813502011418, 00813502010428, 00813502011296, 00813502010022, 00813502010930, 00813502010961, 00813502011425, 00813502010978, 00813502010985, 00813502012958, 00813502012217, 00813502011814, 00813502012972, 00813502012484, 00813502011401

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification