# FDA recall Z-2958-2020

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-08-07.

## Product

WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.

## Reason for recall

Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as  WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2958-2020
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-07
- **Report date:** 2020-09-23
- **Termination date:** 2020-12-23

- **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-2958-2020

## Citation

> AI Analytics. FDA recall Z-2958-2020. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-2958-2020. Source: US FDA. Licensed CC0.

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