# FDA recall Z-1013-2019

> **Boston Scientific Corporation** · Class II · device recall initiated 2018-12-26.

## Product

Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210

## Reason for recall

The sterile barrier may contain packaging seal  defects.

## Distribution

The products were distributed to the following US states:  AL, CA, IL, MD, PA, TN, TX, UT, and WI.    The products were distributed to the following foreign countries:  Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.

## Key facts

- **Recall number:** Z-1013-2019
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-26
- **Report date:** 2019-03-20
- **Termination date:** 2020-04-17

- **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-1013-2019

## Citation

> AI Analytics. FDA recall Z-1013-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-1013-2019. Source: US FDA. Licensed CC0.

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