Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;
Recall
- Recall Number
- Z-1868-2026
- Event Number
- 98463
- Firm
- Angiodynamics, Inc.
- FEI Number
- 1319211
- Product Code
- DQO
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 3, 2026
- Posted
- April 17, 2026
- Address
- 603 Queensbury Ave, Queensbury, NY, 12804-7619
Description
Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;
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.
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.
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.
65 units (13 boxes)