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FDA recall, , High risk

Automated Impella Controller (AIC)

The Automated Impella Controller may delay its purge system blocked alarm when used with certain pumps.

Summary by Recall Canary from the FDA notice

What happened

Abiomed, Inc., of Danvers, Massachusetts, recalled 62 Automated Impella Controllers (AIC) on February 16, 2026, because the "Purge System Blocked" alarm display could be delayed when using first generation Impella 5.5 (0550-0008*) pumps. The FDA added the recall to its Enforcement Report on March 27, 2026. The recall had international distribution in the country of Australia, Canada, France, Germany, Kuwait.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its UDI-DI is listed.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Automated Impella Controller (AIC)

    UDI-DI
    • 00813502011272
    • 00813502011289
    • 00813502011296
    • 00813502010022
    • 00813502010961
    • 00813502010978
    • 00813502012958
    • 00813502012217
    • 00813502012972
    Affected units
    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.

Recall details

Company began the recall
Sold in

International distribution in the country of Australia, Canada, France, Germany, Kuwait.

Company
Abiomed, Inc.Danvers, Massachusetts
Hazard
Device defect
Risk

High risk

There is a reasonable chance that using it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
98393
Recall number
Z-1591-2026
Quantity recalled
62 units

All recalls from Abiomed, Inc.

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Same product, other recalls

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)