Soft-Vu Angiographic Catheter Cobra Non-Braided recalled by Angiodynamics
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The defect prevents proper guidewire passage but no injuries or hospitalizations are reported in the source text. The risk is operational failure rather than an inherent material or pathogenic hazard.
Plain-English summary
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided (Catalog No. 10714018, Lot No. A2825145) worldwide, including the US. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub.
The recalled devices have been distributed in the US 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. A total of 210 units (42 boxes) were distributed.
Physicians and hospitals using these devices should review their inventory and contact Angiodynamics for instructions on return or replacement. Patients who have received treatment with an affected device should contact their healthcare provider.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- 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 CB2 4F X 100CM 038 NB 0SH
- Catalog No.: 10714018
- Product/UPN No.: H787107140185 (Box)
- H787107140180 (Pouch)
- UDI-DI: 25051684007938(Box)
- 15051684007931(Pouch)
- Lot No.: A2825145
Distribution
Distributed nationwide across the United States.
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