Agency classClass IIOur severity:High FDA (Devices)·Z-1861-2026·Announced 2026-04-29

Angiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall

Angiodynamics is recalling specific lots of Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices due to a manufacturing defect that may prevent guidewire passage 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: The recall is classified as FDA Class II and involves a risk-of-harm defect (inability to pass guidewire) that could impede proper medical procedure execution. No reported illnesses or injuries are stated in the source, but the potential for patient harm during an invasive cardiovascular procedure warrants a High severity rating.

Plain-English summary

Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided (Catalog No. 10714011) due to a manufacturing defect. The defect may prevent an appropriately sized guidewire from passing through the inner diameter of the catheter hub, which could compromise the device's intended function during angiographic procedures.

The affected devices are identified by Lot Nos. A3025038 and A3025051. A total of 435 units (87 boxes) have been distributed worldwide, including nationwide in 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.

Healthcare providers and facilities that have received these devices should stop using affected lots and contact Angiodynamics, Inc. directly. Patients who may have received treatment with affected devices should consult their healthcare providers.

The recalled product

Product: Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Cardiovascular / Catheter
Hazard: device-malfunction
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 CB2 4F X 65CM 038 NB 0SH
Catalog No.: 10714011
Product/UPN No.: H787107140115 (Box)
H787107140110 (Pouch)
UDI-DI: 25051684007877(Box)
15051684007870(Pouch)
Lot No.: A3025038
A3025051

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 →

High
Soft-Vu Angiographic Catheter Kumpe Non-Braided manufacturing defect recall
FDA (Devices) · 2026-04-29
High
Soft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect
FDA (Devices) · 2026-04-29
High
AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
High
Soft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
FDA (Devices) · 2026-04-29
High
Soft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall
FDA (Devices) · 2026-04-29

Same hazard · device malfunction