# FDA recall Z-0299-2025

> **Boston Scientific Corporation** · Class I · device recall initiated 2024-10-10.

## Product

Boston Scientific POLARx FIT BALLOON CATHETER ST  OUS, Material Number M004CRBS2010

## Reason for recall

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0299-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-10
- **Report date:** 2024-11-20

- **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-0299-2025

## Citation

> AI Analytics. FDA recall Z-0299-2025. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0299-2025. Source: US FDA. Licensed CC0.

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