Class I

Medical Device Recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.

Abiomed, Inc. · May 22, 2026

Reason for Recall

Potential for thrombus formation during prolonged use of the introducer.

Distribution

Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.

States Affected

NATIONWIDE

Quantity Affected

7 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2602-2026

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.