# FDA recall Z-2350-2024

> **Boston Scientific Corporation** · Class II · device recall initiated 2024-06-12.

## Product

Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.

## Reason for recall

Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.

## Distribution

Domestic distribution nationwide.

## Key facts

- **Recall number:** Z-2350-2024
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-12
- **Report date:** 2024-07-24

- **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-2350-2024

## Citation

> AI Analytics. FDA recall Z-2350-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2350-2024. Source: US FDA. Licensed CC0.

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