Angiodynamics Soft-Vu Angiographic Catheter Kumpe Recall
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe devices due to a manufacturing defect that may prevent guidewire passage through the catheter hub.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a manufacturing defect that prevents proper device function during a critical procedure. Although no illnesses or injuries are reported in the source text, the defect directly impairs a high-risk medical device used in angiographic procedures, creating a risk of harm.
Plain-English summary
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided (Catalog No. 10734301). The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub.
A total of 5,155 units (1,031 boxes) have been distributed worldwide, including US Nationwide and internationally to Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, and Thailand. The affected lot numbers are A2825021, A2825129, A3325027, A3425027, A3525014, and A3825095.
Healthcare facilities and individuals who have received this product should stop use and contact Angiodynamics, Inc. for instructions on return or replacement of affected units.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- manufacturing-defect
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- SOFT-VU KMP 4F X 40CM 035 NB 0SH
- Catalog No.: 10734301
- Product/UPN No.: H787107343015 (Box)
- H787107343010 (Pouch)
- UDI-DI: 25051684010112(Box)
- 15051684010115(Pouch)
- Lot No.: A2825021
- A2825129
- A3325027
- A3425027
- A3525014
- A3825095
Distribution
Distributed nationwide across the United States.
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