# FDA recall Z-1390-2024

> **Boston Scientific Corporation** · Class II · device recall initiated 2024-02-20.

## 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

- **Recall number:** Z-1390-2024
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1390-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1390-2024. Source: US FDA. Licensed CC0.

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