# FDA recall Z-2618-2025

> **Boston Scientific Corporation** · Class II · device recall initiated 2025-08-28.

## Product

Extractor Pro RX Retrieval Balloon Catheter;  UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

## Reason for recall

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

## Distribution

US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.

## Key facts

- **Recall number:** Z-2618-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-28
- **Report date:** 2025-10-01

- **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-2618-2025

## Citation

> AI Analytics. FDA recall Z-2618-2025. Retrieved 2026-08-23 from https://api.ai-analytics.org/recall/Z-2618-2025. Source: US FDA. Licensed CC0.

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