Abiomed, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2319-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: May 31, 2024

Date Posted: July 24, 2024

Recall Number: Z-2319-2024

Event ID: 94833

Reason for Recall:

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

Status: Ongoing

Product Quantity: 9 units

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.

Distribution Pattern:

Domestic only: FL, MA, OH TX.

Voluntary or Mandated:

Voluntary: Firm initiated