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Soft-Vu recallZ-1861-2026 · Angiodynamics, Inc. · initiated Mar 3, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On March 3, 2026 URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: IMMEDIATELY: 1. Stop using the devices subject to this recall and share the notification to all users of the deviceswithin your facility immediately. 2. Provide a copy of this recall notification to all sites or clinics to which you have distributed affectedproduct. 3. Remove any affected items/lots from your inventory (whether in labs, Central Supply, Shipping andReceiving or ANY other location). 4. Segregate this product in a secure location for return to AngioDynamics, Inc. 5. Package and Return the Recalled Product.

Recall details

Recall number
Z-1861-2026
Status
Open, Classified
Initiated by the company
Mar 3, 2026
Posted by the FDA
Apr 17, 2026
Recalling firm
Angiodynamics, Inc.
Quantity
435 units (87 boxes)
Product code
DQO
FDA submissions
K161596, K173762, K112452
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.

Product description

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;

Code information (models, lots, serial numbers)

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;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

66 devices cleared under K161596, K173762, K112452 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98463).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page