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U.S. Department of Health and Human Services

Class 2 Device Recall Angiodynamics SoftVu

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 Class 2 Device Recall Angiodynamics SoftVusee related information
Date Initiated by FirmMarch 03, 2026
Date PostedApril 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1862-2026
Recall Event ID 98463
510(K)NumberK112452 K161596 K173762 
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
ProductSoft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Code Information SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); UDI-DI: 25051684007891(Box), 15051684007894(Pouch); Lot No.: A2825033, A2825034, A2825132, A2825133, A3725048, A3725049;
FEI Number 1319211
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information ContactKasey Newcomb
978-333-1108
Manufacturer Reason
for Recall		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 Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce4925 units (985 boxes)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQO
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