FDA recall Z-2319-2024

Abiomed, Inc. · Class I · device

Product

Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

Reason for recall

Nine (9) Impella CP pumps failed inspection and were inadvertently released.

Distribution

Domestic only: FL, MA, OH TX.

Key facts

Status: Ongoing
Initiation date: 2024-05-31
Report date: 2024-07-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2319-2024