# FDA recall Z-0950-2021

> **Boston Scientific Corporation** · Class I · device recall initiated 2020-12-02.

## Product

EMBLEM S-ICD Model A209

## Reason for recall

Electrical overstress may lead to device malfunction.

## Distribution

Distribution throughout United States and worldwide.  Foreign distribution was made to Canada and other countries.

## Key facts

- **Recall number:** Z-0950-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-02
- **Report date:** 2021-02-17
- **Termination date:** 2022-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0950-2021

## Citation

> AI Analytics. FDA recall Z-0950-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0950-2021. Source: US FDA. Licensed CC0.

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