Class II
Medical Device Recall: Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
PI CARDIA LTD · July 6, 2026
Reason for Recall
Transfemoral catheter, positing arm may detached due to weld issue.
Distribution
US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York.
States Affected
NATIONWIDE
Quantity Affected
46 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3213-2026
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.