Class II
Medical Device Recall: Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Boston Scientific Corporation · February 20, 2024
Reason for Recall
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada.
States Affected
NATIONWIDE
Quantity Affected
4060 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1390-2024
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.