Agency classClass IIOur severity:High FDA (Devices)·Z-1860-2026·Announced 2026-04-29

Soft-Vu Angiographic Catheter Angiodynamics Guidewire Passage Defect

Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The catheters were distributed worldwide including the US.

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: FDA Class II medical device recall where the manufacturing defect creates a risk of harm (obstruction of guidewire passage) that could compromise the device's intended function during a catheterization procedure. No reported illnesses or injuries are mentioned in the source.

Plain-English summary

Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter, Berenstein, Non-Braided (Catalog No. 10714009, SOFT-VU BER 4F X 65CM 038 NB 0SH) with Product/UPN Nos. H787107140095 (Box) and H787107140090 (Pouch). Approximately 1520 units across 304 boxes are affected.

The recalled catheters contain a manufacturing defect that may prevent an appropriately sized guidewire from passing through the inner diameter of the catheter hub.

The affected products were distributed worldwide to the US and 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 A2825134, A2825153, and A3825063.

Patients or healthcare providers who have the affected devices should contact Angiodynamics, Inc. for further instructions.

The recalled product

Product: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Angiographic Catheter
Hazard: guidewire-obstruction
manufacturing-defect

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 (9)

SOFT-VU BER 4F X 65CM 038 NB 0SH
Catalog No.: 10714009
Product/UPN No.: H787107140095 (Box)
H787107140090 (Pouch)
UDI-DI: 25051684007853(Box)
15051684007856(Pouch)
Lot No.: A2825134
A2825153
A3825063

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 · guidewire obstruction