Soft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect
Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing 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. The defect prevents proper guidewire passage through the catheter hub, creating a risk of harm to patients during angiographic procedures. Although no illnesses or injuries are reported in the source text, the functional impairment of a critical interventional device during use constitutes a significant risk that warrants a High severity rating.
Plain-English summary
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided (Catalog No. 10714017). 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.
The recalled product was distributed worldwide, including across the United States and to 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, and Thailand. A total of 80 units (16 boxes) were affected. The specific lot number is A2425089.
Affected customers who have this device should contact Angiodynamics, Inc. for instructions regarding return or replacement.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (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 (7)
- SOFT-VU CB1 4F X 100CM 038 NB 0SH
- Catalog No.: 10714017
- Product/UPN No.: H787107140175 (Box)
- H787107140170 (Pouch)
- UDI-DI: 25051684007921(Box)
- 15051684007924(Pouch)
- Lot No.: A2425089
Distribution
Distributed nationwide across the United States.
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