FDA recall Z-1390-2024

Product

Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system

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.

Key facts

Status

Ongoing

Initiation date

2024-02-20

Report date

2024-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2024