# FDA recall Z-2441-2023

> **Boston Scientific Corporation** · Class II · device recall initiated 2023-07-11.

## Product

EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator

## Reason for recall

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-2441-2023
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-11
- **Report date:** 2023-08-30

- **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-2441-2023

## Citation

> AI Analytics. FDA recall Z-2441-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2441-2023. Source: US FDA. Licensed CC0.

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