Has Boston Scientific Neuromodulation Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 10 total FDA actions tied to Boston Scientific Neuromodulation Corporation: 0 warning letters, 10 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 2024-08-21; 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.

.hq

fda_recall · device_recall · high

Boston Scientific Neuromodulation Corporation — Class II recall: WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232,…

Name: FDA Recall Record — Boston Scientific Neuromodulation Corporation
Creator: Argus HQ
Published: 2024-08-21
License: https://argushq.ai/methodology

Event date: 2024-08-21 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2617-2024
Payload hash: 587605775c954de28fd3955d…

Summary

Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and th… 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 10 total FDA actions tied to Boston Scientific Neuromodulation Corporation: 0 warning letters, 10 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 2024-08-21; 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 (2024). Boston Scientific Neuromodulation Corporation — Class II recall: WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232,…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-2617-2024

MLA

"Boston Scientific Neuromodulation Corporation — Class II recall: WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232,…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-2617-2024.

Chicago

Argus HQ Research. "Boston Scientific Neuromodulation Corporation — Class II recall: WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232,…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-2617-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_neuromodulation_corporation_z_2617_2024_2024,
  title = {Boston Scientific Neuromodulation Corporation — Class II recall: WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232,…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-2617-2024},
  note = {Accessed: July 23, 2026}
}

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