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 2023-06-21; 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: Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-…

Name: FDA Recall Record — Boston Scientific Neuromodulation Corporation
Creator: Argus HQ
Published: 2023-06-21
License: https://argushq.ai/methodology

Event date: 2023-06-21 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1972-2023
Payload hash: c5e2458fd973f467b16b01ec…

Summary

Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed a… 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 2023-06-21; 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 (2023). Boston Scientific Neuromodulation Corporation — Class II recall: Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-1972-2023

MLA

"Boston Scientific Neuromodulation Corporation — Class II recall: Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-1972-2023.

Chicago

Argus HQ Research. "Boston Scientific Neuromodulation Corporation — Class II recall: Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-1972-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_neuromodulation_corporation_z_1972_2023_2023,
  title = {Boston Scientific Neuromodulation Corporation — Class II recall: Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-neuromodulation-corporation-z-1972-2023},
  note = {Accessed: July 23, 2026}
}

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