# FDA recall Z-2756-2026

> **Boston Scientific Corporation** · Class II · device recall initiated 2026-06-11.

## Product

FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01

## Reason for recall

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

## Distribution

Global Distribution. US Nationwide.

## Key facts

- **Recall number:** Z-2756-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-11
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2756-2026

## Citation

> AI Analytics. FDA recall Z-2756-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2756-2026. Source: US FDA. Licensed CC0.

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