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 2025-07-16; 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 Corporation — Class II recall: VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in t…

Name: FDA Recall Record — Boston Scientific Corporation
Creator: Argus HQ
Published: 2025-07-16
License: https://argushq.ai/methodology

Event date: 2025-07-16 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2104-2025
Payload hash: 874ae516fc51920ac3877452…

Summary

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location. 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 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 2025-07-16; 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 (2025). Boston Scientific Corporation — Class II recall: VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in t…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2104-2025

MLA

"Boston Scientific Corporation — Class II recall: VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in t…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-boston-scientific-corporation-z-2104-2025.

Chicago

Argus HQ Research. "Boston Scientific Corporation — Class II recall: VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in t…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2104-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_2104_2025_2025,
  title = {Boston Scientific Corporation — Class II recall: VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in t…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2104-2025},
  note = {Accessed: July 23, 2026}
}

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