Recall Z-1869-2026 ยท DQO Catheter, Intravascular, Diagnostic
Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
| Date | Apr 17, 2026 (initiated Mar 3, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. Packag |
| Quantity | 220 units (44 boxes) |
| 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. |
| FDA record | Open on fda.gov |