Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Produc…

Recall date

March 3, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1860-2026

FDA classification

Class II

Brand / firm

Angiodynamics, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;