FDA recall Z-2457-2026

Product

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Reason for recall

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Distribution

US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan

Key facts

Status

Ongoing

Initiation date

2026-05-18

Report date

2026-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2457-2026