Has Boston Scientific Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 285 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 285 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 2026-05-13; Argus observed and indexed it on 2026-07-09.

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.

.hq

fda_recall · device_recall · high

Boston Scientific Corporation — Class II recall: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRA…

Name: FDA Recall Record — Boston Scientific Corporation
Creator: Argus HQ
Published: 2026-05-13
License: https://argushq.ai/methodology

Event date: 2026-05-13 00:00:00Z
Observed: 2026-07-09 22:52:37Z
Source ID: Z-2048-2026
Payload hash: 1cee7e10fdf05675aab25a50…

Summary

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programmi… Status: Ongoing.

Entities

Boston Scientific Corporation

View source record ↗

Frequently asked questions

Has Boston Scientific Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 285 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 285 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 2026-05-13; Argus observed and indexed it on 2026-07-09.
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 (2026). Boston Scientific Corporation — Class II recall: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRA…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2048-2026

MLA

"Boston Scientific Corporation — Class II recall: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRA…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-boston-scientific-corporation-z-2048-2026.

Chicago

Argus HQ Research. "Boston Scientific Corporation — Class II recall: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRA…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2048-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_2048_2026_2026,
  title = {Boston Scientific Corporation — Class II recall: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRA…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2048-2026},
  note = {Accessed: August 27, 2026}
}

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