Angiodynamics, Inc.: Device Recall

Recall #Z-2454-2024 · 06/18/2024

Class II: Risk

Recall Details

Recall Number: Z-2454-2024
Classification: Class II
Product Type: Device
Recalling Firm: Angiodynamics, Inc.
Status: Ongoing
Date Initiated: 06/18/2024
Location: Queensbury, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 595 boxes

Reason for Recall

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

Product Description

SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701

Distribution Pattern

US Nationwide distribution.

Other Recalls by Angiodynamics, Inc.

Class II: Risk 02/04/2025

Product is mislabeled with the incorrect fill volume.
Class II: Risk 11/25/2024

Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Class II: Risk 06/18/2024

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Class II: Risk 05/21/2024

A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).

View all recalls by Angiodynamics, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.