Agency classClass IIOur severity:High FDA (Devices)·Z-1862-2026·Announced 2026-04-29

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided manufacturing defect

Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe, 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 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: This is an FDA Class II medical device recall. The defect presents a functional risk—guidewire passage failure could prevent proper catheter use during angiographic procedures—and the source text does not report any illnesses or injuries, meeting the criterion for a High severity score under the rubric.

Plain-English summary

Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided (Catalog No. 10714014) due to a manufacturing defect affecting the inner diameter of the catheter hub. The defect may prevent an appropriately sized guidewire from passing through the hub, potentially compromising the device's intended function during angiographic procedures.

The recall affects 4,925 units (985 boxes) distributed worldwide, including throughout 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. The affected lot numbers are A2825033, A2825034, A2825132, A2825133, A3725048, and A3725049.

Patients and healthcare providers who have this device in stock or have received it should contact Angiodynamics, Inc. for instructions on how to proceed. Affected devices should not be used until guidance is received from the manufacturer.

The recalled product

Product: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Angiographic Catheter
Hazard: device-malfunction
guidewire-incompatibility

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 (12)

SOFT-VU KMP 4F X 65CM 038 NB 0SH
Catalog No.: 10714014
Product/UPN No.: H787107140145 (Box)
H787107140140 (Pouch)
UDI-DI: 25051684007891(Box)
15051684007894(Pouch)
Lot No.: A2825033
A2825034
A2825132
A2825133
A3725048
A3725049

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 malfunction