# FDA recall Z-2977-2026

> **Boston Scientific Corporation** · Class I · device recall initiated 2026-07-09.

## Product

Boston Scientific ENROUTE Transcarotid Neuroprotection System,  Material Number SR-200-NPS; Percutaneous catheter

## Reason for recall

Potential for arterial sheath tip separation or partial tip separation during use.

## Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica

## Key facts

- **Recall number:** Z-2977-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-09
- **Report date:** 2026-08-26

- **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-2977-2026

## Citation

> AI Analytics. FDA recall Z-2977-2026. Retrieved 2026-09-21 from https://api.ai-analytics.org/recall/Z-2977-2026. Source: US FDA. Licensed CC0.

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