# FDA recall Z-1024-2025

> **Boston Scientific Corporation** · Class II · device recall initiated 2024-12-20.

## Product

AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm  UPN: M00553640

## Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

## Distribution

Nationwide including Puerto Rico Foreign: To be provided

## Key facts

- **Recall number:** Z-1024-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-20
- **Report date:** 2025-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1024-2025

## Citation

> AI Analytics. FDA recall Z-1024-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1024-2025. Source: US FDA. Licensed CC0.

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