Agency classClass IIOur severity:High FDA (Devices)·Z-1858-2026·Announced 2026-04-29

Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided recalled for manufacturing defect

Angiodynamics is recalling Soft-Vu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The defect affects 1,550 units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a structural defect that impairs device function—specifically, obstruction preventing guidewire passage—which presents a risk of harm in clinical use. No reported injuries or illnesses are stated in the source, so this meets the High threshold under the rubric.

Plain-English summary

Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided (Catalog No. 10714001) due to a manufacturing defect in the catheter hub. The defect may prevent an appropriately sized guidewire from passing through the inner diameter of the hub.

A total of 1,550 units (155 boxes) have been distributed worldwide, including throughout the United States and to Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, and Thailand.

The affected product has UPN numbers H787107140015 (Box) and H787107140010 (Pouch), and lot numbers A2425078, A3325036, A3525030, A3525031, and A3725102. Customers who have this product should contact Angiodynamics for guidance.

The recalled product

Product: Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Interventional / Catheter
Hazard: device-malfunction
guidewire-obstruction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

SOFT-VU OF 4F X 65CM 038 NB 6SH
Catalog No.: 10714001
Product/UPN No.: H787107140015 (Box)
H787107140010 (Pouch)
UDI-DI: 25051684007778(Box)
15051684007771(Pouch)
Lot No.: A2425078
A3325036
A3525030
A3525031
A3725102

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Same manufacturer · Angiodynamics, Inc.

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Same hazard · device malfunction