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Open, Classified

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.

FDA Recall Z-1591-2026 · Posted 2026-03-27

Recalling FirmAbiomed, Inc.
Recall StatusOpen, Classified
Product CodeOZD
Date Initiated2026-02-16
Product Quantity62 units

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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