Home / Recalls / Abiomed, Inc. / Z-2319-2024

Z-2319-2024 Class I Ongoing

Recalled by Abiomed, Inc. — Danvers, MA

Recall Details

Product Type
Devices
Report Date
July 24, 2024
Initiation Date
May 31, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

Product Description

Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

Reason for Recall

Nine (9) Impella CP pumps failed inspection and were inadvertently released.

Distribution Pattern

Domestic only: FL, MA, OH TX.

Code Information

Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.

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)