Z-1859-2026 Class II Ongoing
FDA device recall Z-1859-2026 was initiated by Angiodynamics, Inc. on March 3, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 950 units (95 boxes).
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- March 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 950 units (95 boxes)
Product Description
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
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.
Distribution Pattern
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.
Code Information
SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); UDI-DI: 25051684007785(Box), 15051684007788(Pouch); Lot No.: A2525060, A2525061, A3625006, A3625007;