Medical Device Recall: Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5
Angiodynamics, Inc. · March 3, 2026
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.
Product Description
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
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.
States Affected
NATIONWIDE
Quantity Affected
220 units (44 boxes)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1869-2026
Status: ongoing
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