Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1865-2026·Announced 2026-04-29

Soft-Vu Angiographic Catheter Cobra Non-Braided recalled by Angiodynamics

Angiodynamics is recalling Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall. The defect prevents proper guidewire passage but no injuries or hospitalizations are reported in the source text. The risk is operational failure rather than an inherent material or pathogenic hazard.

Plain-English summary

Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided (Catalog No. 10714018, Lot No. A2825145) worldwide, including the US. 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 recalled devices have been distributed in the US 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. A total of 210 units (42 boxes) were distributed.

Physicians and hospitals using these devices should review their inventory and contact Angiodynamics for instructions on return or replacement. Patients who have received treatment with an affected device should contact their healthcare provider.

The recalled product

Product: Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Cardiovascular / Catheter
Hazard: device-malfunction

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 CB2 4F X 100CM 038 NB 0SH
Catalog No.: 10714018
Product/UPN No.: H787107140185 (Box)
H787107140180 (Pouch)
UDI-DI: 25051684007938(Box)
15051684007931(Pouch)
Lot No.: A2825145

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 · device malfunction