Abiomed, Inc.: Medical Device Recall in 2026 - (Recall #: Z-1030-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 4, 2025

Date Posted: January 14, 2026

Recall Number: Z-1030-2026

Event ID: 98086

Reason for Recall:

Device packaged in incorrect outer box carton.

Status: Ongoing

Product Quantity: 2 units

Code Information:

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

Distribution Pattern:

International distribution to the country of Australia.

Voluntary or Mandated:

Voluntary: Firm initiated