Class I

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

Abiomed, Inc. · May 31, 2024

Reason for Recall

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

Distribution

Domestic only: FL, MA, OH TX.

States Affected

FL, MA, OH, TX

Quantity Affected

9 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2319-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.