Angiodynamics, Inc. recalls AccuVu Angiographic Catheter

Recalling company

Angiodynamics, Inc.

Product

AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (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

105 units (21 boxes)

Lot / codes

ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch); UDI-DI: 25051684006085(Box), 15051684006088(Pouch); Lot No.: A2825131;

Company location

Queensbury, NY

Recall type

Voluntary: Firm initiated

Recall number

Z-1875-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1875-2026 in the FDA Enforcement Report. Also see FDA recall press releases.