FDA-Device2024-04-03Class II
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Boston Scientific Corporation
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada.
Affected count
4060 devices
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2024Don't want to check this manually?
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