Agency classClass IIOur severity:High FDA (Devices)·Z-1863-2026·Announced 2026-04-29

Soft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall

Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent the guidewire from passing through the catheter hub. The defect affects 1,030 units distributed worldwide.

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 FDA classified this as a Class II recall. The source does not report any actual injuries or illnesses, only a manufacturing defect that may prevent proper device function. A functional defect in a medical device intended for vascular access presents risk of harm even without reported incidents, meeting the High criterion.

Plain-English summary

Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Berenstein, Non-Braided (Catalog No. 10714016, UPN H787107140165/H787107140160) due to a manufacturing defect in the catheter hub's inner diameter.

The defect may prevent an appropriately sized guidewire from passing through the catheter hub, potentially compromising the device's intended function during angiographic procedures.

The recall affects 1,030 units (206 boxes) with Lot No. A2525098, distributed worldwide including the United States and 21 other countries: 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 patients who have these devices should contact Angiodynamics, Inc. for guidance on returns, replacement, or further assistance. Unused devices should not be distributed or used.

The recalled product

Product: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Angiographic Catheter
Hazard: device-malfunction
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 (7)

SOFT-VU BER 4F X 100CM 038 NB 0SH
Catalog No.: 10714016
Product/UPN No.: H787107140165 (Box)
H787107140160 (Pouch)
UDI-DI: 25051684007914(Box)
15051684007917(Pouch)
Lot No.: A2525098

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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