---
title: "EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardiov... — FDA record Z-2442-2023 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-2442-2023-emblem-mri-s-icd-pulse-generator-model-a219-subcutaneous-implantable-cardioverter-defibrillator/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator — FDA record Z-2442-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 11, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Boston Scientific Corporation
- **Quantity**: 41,411 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2442-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2442-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Aug 30, 2023
- **Recall initiation date**: Jul 11, 2023
- **Center classification date**: Aug 22, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2442-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)