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fda_recall · device_recall · high

Boston Scientific Corporation — Class II recall: EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition dire…

Event date
2024-04-17 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-1516-2024
Payload hash
15ee06e486d094279a522f69

Summary

Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture… Status: Ongoing.

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 2024-04-17; 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 Corporation — Class II recall: EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition dire…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1516-2024
MLA
"Boston Scientific Corporation — Class II recall: EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition dire…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-boston-scientific-corporation-z-1516-2024.
Chicago
Argus HQ Research. "Boston Scientific Corporation — Class II recall: EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition dire…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1516-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_1516_2024_2024,
  title = {Boston Scientific Corporation — Class II recall: EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition dire…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1516-2024},
  note = {Accessed: July 23, 2026}
}

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