Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter

Recalling company

Angiodynamics, Inc.

Product

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Mar 3, 2026

Reported

Apr 29, 2026

Distribution

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.

Status

Ongoing

Quantity

210 units (42 boxes)

Lot / codes

SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); UDI-DI: 25051684007938(Box), 15051684007931(Pouch); Lot No.: A2825145;

Company location

Queensbury, NY

Recall type

Voluntary: Firm initiated

Recall number

Z-1865-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1865-2026 in the FDA Enforcement Report. Also see FDA recall press releases.