The Recall Desk
HighFDA (Devices)·Z-1591-2026·Announced 2026-04-08

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

Pending LLM rewrite. Source: FDA_DEVICE Z-1591-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

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; Produc
Manufacturer
Abiomed, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distribution scope not specified by the agency.

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