Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2

Device packaged in incorrect outer box carton.

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

The consignee was sent a RECALL notice dated 12/4/25. The consignee is instructed to identify the two affected pumps in their inventory, quarantine them, and return the units to Abiomed, Danvers. The consignee is to complete and return the provided business reply form to their local Abiomed representative.

• FDA enforcement recordOfficial FDA database entry for Z-1030-2026
• FDA device classification · OZDOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Abiomed, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.