Home / Recalls / Abiomed, Inc. / Z-1030-2026

Z-1030-2026 Class II Ongoing

Recalled by Abiomed, Inc. — Danvers, MA

Recall Details

Product Type
Devices
Report Date
January 14, 2026
Initiation Date
December 4, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Reason for Recall

Device packaged in incorrect outer box carton.

Distribution Pattern

International distribution to the country of Australia.

Code Information

Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27.

Other recalls by Abiomed, Inc.

  • Z-1470-2026 Class I — Impella RP Flex with SmartAssist. Product Code: 1000323. (January 27, 2026)
  • Z-1471-2026 Class I — Impella RP. Product Code: 0046-0011. (January 27, 2026)
  • Z-1469-2026 Class I — Impella RP with SmartAssist. Product Code: 0046-0035. (January 27, 2026)
  • 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)
  • Z-0829-2025 Class I — Impella RP with SmartAssist; Product Number: 0046-0035; (December 12, 2024)
  • Z-0830-2025 Class I — Impella RP Flex with SmartAssist; Product Number: 1000323; (December 12, 2024)
  • Z-2957-2024 Class II — Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; (August 5, 2024)