Has Boston Scientific Neuromodulation Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 11 total FDA actions tied to Boston Scientific Neuromodulation Corporation: 0 warning letters, 11 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 critical severity by Argus HQ. FDA published the underlying record on 2026-08-12; Argus observed and indexed it on 2026-08-19.

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 · critical

Boston Scientific Neuromodulation Corporation — Class I recall: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINI…

Name: FDA Recall Record — Boston Scientific Neuromodulation Corporation
Creator: Argus HQ
Published: 2026-08-12
License: https://argushq.ai/methodology

Event date: 2026-08-12 00:00:00Z
Observed: 2026-08-19 04:20:42Z
Source ID: Z-2879-2026
Payload hash: 4cfcc3abfc7aade0ca6ada81…

Summary

Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement. Status: Ongoing.

Entities

Boston Scientific Neuromodulation Corporation

View source record ↗

Frequently asked questions

Has Boston Scientific Neuromodulation Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 11 total FDA actions tied to Boston Scientific Neuromodulation Corporation: 0 warning letters, 11 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 critical severity by Argus HQ. FDA published the underlying record on 2026-08-12; Argus observed and indexed it on 2026-08-19.
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 Neuromodulation Corporation — Class I recall: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500;   INFINI…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-2879-2026

MLA

"Boston Scientific Neuromodulation Corporation — Class I recall: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500;   INFINI…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-2879-2026.

Chicago

Argus HQ Research. "Boston Scientific Neuromodulation Corporation — Class I recall: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500;   INFINI…." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-2879-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_neuromodulation_corporation_z_2879_2026_2026,
  title = {Boston Scientific Neuromodulation Corporation — Class I recall: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500;   INFINI…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-2879-2026},
  note = {Accessed: August 19, 2026}
}

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