Agency classClass IIOur severity:Severe FDA (Devices)·Z-1867-2026·Announced 2026-04-29

Soft-Vu Angiographic Catheter Soft-Vu SO1 recalled for manufacturing defect

Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided due to a manufacturing defect that 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II medical device recall. The manufacturing defect prevents proper device function during a procedure, which poses a risk of harm to patients during angiographic procedures, meeting the threshold for Severe classification.

Plain-English summary

Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided (Model: SOFT-VU SO1 4F X 80CM 038 NB 0SH, Catalog No. 10714024). 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.

This recall affects 320 units (64 boxes) that were distributed worldwide, including the US Nationwide and internationally 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 lot numbers are A2825152 and A3225009.

Healthcare providers and patients who have this device should contact Angiodynamics, Inc. for instructions on how to proceed. Patients should not use affected units and should consult with their healthcare provider regarding any concerns.

The recalled product

Product: Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Angiographic 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 (8)

SOFT-VU SO1 4F X 80CM 038 NB 0SH
Catalog No.: 10714024
Product/UPN No.: H787107140245 (Box)
H787107140240 (Pouch)
UDI-DI: 25051684007983(Box)
15051684007986(Pouch)
Lot No.: A2825152
A3225009

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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