Reported Apr 29, 2026 · Ongoing
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN…
Angiodynamics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619
Is this the product you have?
- Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch)
- Box Quantity5 pouches
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published — SOFT-VU KMP 4F X 40CM 035 NB 0SH 10734301— — Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch) — 2505168401011215051684010115UDI-DI: 25051684010112(Box), 15051684010115(Pouch) — Lot No.: A2825021, A2825129, A3325027, A3425027, A3525014, A3825095 - Amount recalled
- 5155 units (1031 boxes)
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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