Recall Z-2457-2026— Abiomed, Inc.

Name: FDA recall Z-2457-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-18

Class I · Ongoing

Class I FDA medical device recall by Abiomed, Inc., initiated 2026-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.. Reason: 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..

Recalling firm: Abiomed, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-05-18
Firm location: Danvers, MA, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.