Home / Recalls / Abiomed, Inc. / Z-0441-2024

Z-0441-2024 Class II Terminated

Recalled by Abiomed, Inc. — Danvers, MA

Recall Details

Product Type
Devices
Report Date
December 13, 2023
Initiation Date
October 10, 2023
Termination Date
March 6, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

Reason for Recall

Pump not detected as connected to controller due to software issue.

Distribution Pattern

US: AZ, CA, FL, NY & VA.

Code Information

UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617.

Other recalls by Abiomed, Inc.

  • Z-1589-2026 Class I — Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled (February 18, 2026)
  • Z-1591-2026 Class I — Automated Impella Controller (AIC), labeled as the following with corresponding (February 16, 2026)
  • Z-1469-2026 Class I — Impella RP with SmartAssist. Product Code: 0046-0035. (January 27, 2026)
  • Z-1471-2026 Class I — Impella RP. Product Code: 0046-0011. (January 27, 2026)
  • Z-1470-2026 Class I — Impella RP Flex with SmartAssist. Product Code: 1000323. (January 27, 2026)
  • Z-1030-2026 Class II — Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. (December 4, 2025)
  • Z-0069-2026 Class I — Automated Impella Controller (AIC), used for left heart support blood pump, labe (October 1, 2025)
  • Z-0136-2026 Class I — Automated Impella Controller (AIC) labeled as the following with corresponding P (September 16, 2025)
  • Z-2568-2025 Class I — Automated Impella Controller (AIC) with the below brands and product codes. Used (August 20, 2025)
  • Z-2164-2025 Class I — Automated Impella Controller (AIC), used in left heart support blood pump, inclu (June 23, 2025)