Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product
FDA device recall Z-1860-2026 · posted 2026-04-17 · Open, Classified
Recall details
- Recalling firm
- Angiodynamics, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- DQO
- Quantity affected
- 1520 units (304 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 Zeala
- Date initiated
- 2026-03-03
- Date posted
- 2026-04-17
- Location
- Queensbury, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters (K173762) | AngioDynamics, Inc. | 2018-07-18 |
| Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters (K161596) | AngioDynamics, Inc. | 2017-04-28 |
| ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS (K112452) | AngioDynamics, Inc. | 2012-03-30 |