Agency classClass IIOur severity:High FDA (Devices)·Z-1859-2026·Announced 2026-04-29

Soft-Vu pigtail angiographic catheters may block the appropriately sized guidewire

Soft-Vu Pigtail Angiographic Catheters are being recalled because a manufacturing defect may prevent an appropriately sized guidewire from passing through the catheter hub.

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: FDA Class II recall where a manufacturing defect can obstruct guidewire passage during a procedure, a risk of harm with no injuries reported in the source.

Plain-English summary

The Soft-Vu Angiographic Catheter, Pigtail, Non-Braided, 4F x 65 cm, catalog number 10714002, is being recalled. The action covers 950 units in 95 boxes of 10 pouches.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub. The FDA classified the action as Class II.

Distribution was worldwide, covering the United States nationwide and Austria, Australia, Belgium, Canada and other markets. The catheters are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the catalog number, product number and UDI-DI in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.

The recalled product

Product: Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Angiographic catheter
Hazard: manufacturing-defect
guidewire-obstruction
class-ii
angiography

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 (10)

SOFT-VU PT 4F X 65CM 038 NB 10SH
Catalog No.: 10714002
Product/UPN No.: H787107140025 (Box)
H787107140020 (Pouch)
UDI-DI: 25051684007785(Box)
15051684007788(Pouch)
Lot No.: A2525060
A2525061
A3625006
A3625007

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.

See all →

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Same hazard · manufacturing defect