FDAFDA · Food and drugs·Recall number Z-1862-2026
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Published April 29, 2026 · Recall initiated: March 3, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics, Inc.
- Distributor
- 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.
- Lot
- SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); UDI-DI: 25051684007891(Box), 15051684007894(Pouch); Lot No.: A2825033, A2825034, A2825132, A2825133, A3725048, A3725049;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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