Lower risk Medical device recall · FDA · Published July 11, 2023

Boston Scientific EMBLEM S-ICD Pulse Generator Model A209 Recall: Potential LATITUDE

Boston Scientific recalls EMBLEM S-ICD Pulse Generator Model A209 for rare interaction with LATITUDE communicator that may cause temporary S-ICD sensing disablement. Affected units have specific GTINs and are enrolled in LATITUDE.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2441-2023Medical device Boston Scientific ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBoston Scientific Corporation4100 Hamline Ave N · Saint Paul, MN 55112-5700

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling EMBLEM S-ICD Pulse Generator Model A209 devices due to a rare interaction with LATITUDE communicators that could temporarily disable the device's sensing function. This may require medical attention if the device fails to sense heart rhythms properly. Read more at govinfonow.com/recall/57725-boston-scientific-emblem-s-icd-pulse-generator-model-a209-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/57725-boston-scientific-emblem-s-icd-pulse-generator-model-a209-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2441-2023

Cite this page

“Boston Scientific EMBLEM S-ICD Pulse Generator Model A209 Recall: Potential LATITUDE.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57725-boston-scientific-emblem-s-icd-pulse-generator-model-a209-recall. Based on FDA recall #Z-2441-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2441-2023%22&limit=1).

The FDA announced on July 11, 2023, that Boston Scientific Corporation is recalling EMBLEM S-ICD Pulse Generator Model A209 devices due to a potential interaction with the LATITUDE communicator. This issue may cause sensing disablement for a 24-hour interval. The recall affects 3,856 units distributed worldwide.

How to tell if you have it

EMBLEM S-ICD Pulse Generator Model A209
Subcutaneous Implantable Cardioverter Defibrillator
UPC 00802526544101
UPC 00802526548406
UPC 00802526575105
UPC 00802526575112
UPC 00802526575129
UPC 00802526575136
UPC 00802526575143
UPC 00802526575167
UPC 00802526575181
UPC 00802526575204
UPC 00802526575211
UPC 00802526575228
UPC 00802526599002

The hazard

According to the FDA, there is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator. This interaction may cause S-ICD sensing disablement for a 24-hour interval.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the Aug. 24, 2026, Imager II Angiographic Catheters Recall for tip fracture risk and the Aug. 6, 2026, LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts. Other recent recalls of similar products include the July 1, 2026, Philips Cardiac Workstation 5000 recall and the July 1, 2026, Philips Cardiac Workstation 7000 recall, both involving inaccurate heart rate data risk.

How to tell if you have this one

Check for the EMBLEM S-ICD Pulse Generator Model A209 with specific GTIN numbers listed in the recall. Devices enrolled in LATITUDE communication systems are also affected.

Brand
Boston Scientific
Product
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide

Recall number	Product, codes & lots	Quantity
Z-2441-2023	EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator; GTIN: 00802526544101, 00802526548406, 00802526575105, 00802526575112, 00802526575129, 00802526575136, 00802526575143, 00802526575167, 00802526575181, 00802526575204, 00802526575211, 00802526575228, 00802526599002; All EMBLEM S-ICDs enrolled in LATITUDE	3,856 units
Z-2442-2023	EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator; GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE	41,411 units

Based on the official FDA remedy

What to do — step by step

Check Device Enrollment
Verify if your EMBLEM S-ICD is enrolled in LATITUDE communication systems using the device's model and GTIN numbers provided in the recall.

How this recall unfolded

Recall timeline

FDA published this recall 50 days after the firm started it.

Jul 11, 2023Firm started the recall
Aug 22, 2023FDA classified it Class II
Aug 30, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/57725-boston-scientific-emblem-s-icd-pulse-generator-model-a209-recall">Boston Scientific EMBLEM S-ICD Pulse Generator Model A209 Recall: Potential LATITUDE (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2441-2023 (July 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2441-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.