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fda_recall · device_recall · high

Angiodynamics, Inc. — Class II recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 0…

Event date
2026-04-29 00:00:00Z
Observed
2026-07-09 22:52:56Z
Source ID
Z-1860-2026
Payload hash
58b4c5f8052c9d7c079c843f

Summary

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. Status: Ongoing.

Frequently asked questions

Has Angiodynamics, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 20 total FDA actions tied to Angiodynamics, Inc.: 0 warning letters, 20 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 2026-04-29; Argus observed and indexed it on 2026-07-09.
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). Angiodynamics, Inc. — Class II recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided;  SOFT-VU BER 4F X 65CM 0…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-angiodynamics-inc-z-1860-2026
MLA
"Angiodynamics, Inc. — Class II recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided;  SOFT-VU BER 4F X 65CM 0…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-angiodynamics-inc-z-1860-2026.
Chicago
Argus HQ Research. "Angiodynamics, Inc. — Class II recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided;  SOFT-VU BER 4F X 65CM 0…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-angiodynamics-inc-z-1860-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_angiodynamics_inc_z_1860_2026_2026,
  title = {Angiodynamics, Inc. — Class II recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided;  SOFT-VU BER 4F X 65CM 0…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-angiodynamics-inc-z-1860-2026},
  note = {Accessed: August 27, 2026}
}

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