# FDA recall Z-0152-2023

> **Boston Scientific Corporation** · Class II · device recall initiated 2022-09-30.

## Product

EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.

## Reason for recall

There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

## Distribution

Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA.  The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.

## Key facts

- **Recall number:** Z-0152-2023
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-30
- **Report date:** 2022-11-09

- **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-0152-2023

## Citation

> AI Analytics. FDA recall Z-0152-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0152-2023. Source: US FDA. Licensed CC0.

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