Recall Z-1390-2024— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2024-02-20. It names 4 FDA 510(k) clearances: K233503, K230051, K191871 and 1 more. Product: Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system. Reason: 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-20
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
4 on FDA's record- K233503 — 14F iSLEEVE Introducer Set
- K230051 — 14F iSLEEVE Introducer Set
- K191871 — 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
- K180785 — iSLEEVE Introducer Set
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.