# FDA recall Z-0551-2020

> **Boston Scientific Corporation** · Class II · device recall initiated 2019-10-21.

## Product

Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640

## Reason for recall

Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

## Distribution

Nationwide  Foreign:   Austria  Australia  Belgium  Bulgaria  Croatia  Czech Rep  Denmark  Finland  France  Germany  Great Britain  Italy  Japan  Pakistan  Poland  Russian Fed.  Slovakia  South Africa  Spain  Sweden  Switzerland  Thailand  Turkey

## Key facts

- **Recall number:** Z-0551-2020
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-21
- **Report date:** 2019-12-04
- **Termination date:** 2023-12-20

- **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-0551-2020

## Citation

> AI Analytics. FDA recall Z-0551-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0551-2020. Source: US FDA. Licensed CC0.

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