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fda_recall · device_recall · high

Boston Scientific Corporation — Class II recall: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter D…

Event date
2023-08-30 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-2441-2023
Payload hash
0a7c835c14b52a6347264fb7…

Summary

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. Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Boston Scientific Corporation had other FDA enforcement actions?
Yes. Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 272 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2023-08-30; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2023). Boston Scientific Corporation — Class II recall: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter D…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2441-2023
MLA
"Boston Scientific Corporation — Class II recall: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter D…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-boston-scientific-corporation-z-2441-2023.
Chicago
Argus HQ Research. "Boston Scientific Corporation — Class II recall: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter D…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2441-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_2441_2023_2023,
  title = {Boston Scientific Corporation — Class II recall: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter D…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2441-2023},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.

Boston Scientific Corporation — Class II recall: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter D… · Argus HQ