Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/…
- Recall date
- March 3, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1856-2026
- FDA classification
- Class II
- Brand / firm
- Angiodynamics, Inc.
- Sold / distributed
- 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.
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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;
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