Agency classClass IIOur severity:High FDA (Devices)·Z-1871-2026·Announced 2026-04-29

Angiodynamics Soft-Vu Angiographic Catheter Kumpe Recall

Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe 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: This is an FDA Class II medical device recall involving a manufacturing defect that prevents proper device function during a critical procedure. Although no illnesses or injuries are reported in the source text, the defect directly impairs a high-risk medical device used in angiographic procedures, creating a risk of harm.

Plain-English summary

Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided (Catalog No. 10734301). The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub.

A total of 5,155 units (1,031 boxes) have been distributed worldwide, including 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 A2825021, A2825129, A3325027, A3425027, A3525014, and A3825095.

Healthcare facilities and individuals who have received this product should stop use and contact Angiodynamics, Inc. for instructions on return or replacement of affected units.

The recalled product

Product: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Cardiovascular / Catheter
Hazard: manufacturing-defect
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 (12)

SOFT-VU KMP 4F X 40CM 035 NB 0SH
Catalog No.: 10734301
Product/UPN No.: H787107343015 (Box)
H787107343010 (Pouch)
UDI-DI: 25051684010112(Box)
15051684010115(Pouch)
Lot No.: A2825021
A2825129
A3325027
A3425027
A3525014
A3825095

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 · manufacturing defect