Recall Z-1863-2026
Angiodynamics, Inc. · initiated March 3, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
Codes / lots: SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); UDI-DI: 25051684007914(Box), 15051684007917(Pouch); Lot No.: A2525098;
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: Nonconforming Material/Component
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.
Details
- Recall number
- Z-1863-2026
- Initiated
- March 3, 2026
- Posted by FDA
- April 17, 2026
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Quantity
- 1030 units (206 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.
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1856-2026 Class II | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1857-2026 Class II | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1858-2026 Class II | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1859-2026 Class II | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1860-2026 Class II | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1861-2026 Class II | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1862-2026 Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1864-2026 Class II | Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1865-2026 Class II | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1866-2026 Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1867-2026 Class II | Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1868-2026 Class II | Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1869-2026 Class II | Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1870-2026 Class II | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1871-2026 Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1872-2026 Class II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1873-2026 Class II | AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1874-2026 Class II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |
| Z-1875-2026 Class II | AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | 03/03/2026Open, Classified |