FDA recall Z-1030-2026

Product

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

International distribution to the country of Australia and Taiwan.

Key facts

Status

Ongoing

Initiation date

2025-12-04

Report date

2026-01-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1030-2026