Z-1591-2026Class I

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella...

Name: Z-1591-2026 Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella...
Creator: Abiomed, Inc.
Published: 2026-02-16
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2026-02-16 / Open, Classified / root cause: software

FDA source

Abiomed, Inc. began a recall of Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA... on 2026-02-16. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1591-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-02-16
Posted: 2026-03-27
Recalling firm: Abiomed, Inc.
Product: 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.
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
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.
Root cause tag: software
FDA root cause: Software design
Action: Abiomed notified international consignees on about 02/16/2026 via emailed CRITICAL PRODUCT CORRECTION letter. Consignees were instructed to cease use of the Automated Impella Controller (AIC) with an Impella 5.5 S1 (product code 0550-0007) unless AIC software is updated to v10.1 or above, identify current software in the lower left corner of the initial AIC display screen, contact your local Abiomed representative to schedule your software update, review and complete the customer response form provided and post this notification in a visible area for awareness. Consignees were also instructed to forward this notification to anyone within the facility that should be aware and forward the notification to consignees if further distributed.
Quantity in commerce: 62 units
Distribution: International distribution in the country of Australia, Canada, France, Germany, Kuwait.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1591-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1591-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27

Product code OZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)