FDA Medical devices recall ·
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided recall
- Recall number
- Z-1856-2026
- Date
- (initiated March 3, 2026)
- Company / brand
- Angiodynamics, Inc.
603 Queensbury Ave, Queensbury, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 450 units (45 boxes)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); UDI-DI: 25051684006177 (Box), 15051684006170 (Pouch); Lot No.: A3325043;
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1856-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.