Z-2454-2024Class II

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

Name: Z-2454-2024 SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Creator: Angiodynamics, Inc.
Published: 2024-06-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-06-18 / Open, Classified / root cause: packaging

FDA source

Angiodynamics, Inc. began a recall of SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701 on 2024-06-18. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2454-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-18
Posted: 2024-07-31
Recalling firm: Boston Scientific Corporation
Product: SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Product code: DQO Catheter, Intravascular, Diagnostic
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)
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Angiodynmaics issued Urgent Medical Device Recall Letter on 6/18/24 via Federal Express to end-users. Letter states reason for recall, health risk and action to take: " IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form. Email Reply Verification Tracking Form (preferred): [email protected] Fax Reply Verification Tracking Form: Attn: Soft-Vu Kumpe Recall Coordinator Fax number 1-855-273-0519 " Call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 6:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. " Report any Adverse reactions or quality problems associated with recalled devices to US FDA via MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 3. Package and Return the Recalled Product. " Package any product that is being returned in an appropriate shipping box. " Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. " Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: Soft-Vu Kumpe Recall Coordinator
Quantity in commerce: 595 boxes
Distribution: US Nationwide distribution.
Product codes and lots: UPN: H787107327015 UDI-DI: 25051684009772 (Box) 15051684009775 (Pouch) Lot Number: A0424031

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2454-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2453-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-07	2024-07-31
Z-2454-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-07	2024-07-31

Product code DQO

K173762Class IIAngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc. / cleared 2018-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)