Agency classClass IIOur severity:High FDA (Devices)·Z-1868-2026·Announced 2026-04-29

Soft-Vu Angiographic Catheter Headhunter recalled due to manufacturing defect

Angiodynamics is recalling Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided devices because a manufacturing defect may prevent guidewires 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 classified this as a Class II recall. The defect—obstruction of guidewire passage through the catheter hub—creates a direct risk of harm during vascular interventional procedures, even though no reported illnesses or injuries are documented in the source text. This constitutes a high-risk functional defect on medical equipment used in critical procedures.

Plain-English summary

Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided (Model: SOFT-VU HH1 4F X 100CM 038 NB 0SH, Catalog No. 10714040) distributed worldwide. The affected devices contain a manufacturing defect that may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub.

The recall affects 65 units (13 boxes) of this device. The affected lot number is A2725049, with UDI-DI 25051684008102 (box) and 15051684008105 (pouch). Distribution included US nationwide and international markets including 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.

Healthcare facilities and clinicians who have received this product should contact Angiodynamics, Inc. immediately for instructions on return and replacement. Do not use affected units with lot number A2725049.

The recalled product

Product: Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Angiographic Catheter
Hazard: device-obstruction
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 (7)

SOFT-VU HH1 4F X 100CM 038 NB 0SH
Catalog No.: 10714040
Product/UPN No.: H787107140405 (Box)
H787107140400 (Pouch)
UDI-DI: 25051684008102(Box)
15051684008105(Pouch)
Lot No.: A2725049

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 obstruction