Angiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
Angiodynamics is recalling specific lots of Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided 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: The recall is classified as FDA Class II and involves a risk-of-harm defect (inability to pass guidewire) that could impede proper medical procedure execution. No reported illnesses or injuries are stated in the source, but the potential for patient harm during an invasive cardiovascular procedure warrants a High severity rating.
Plain-English summary
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided (Catalog No. 10714011) due to a manufacturing defect. The defect may prevent an appropriately sized guidewire from passing through the inner diameter of the catheter hub, which could compromise the device's intended function during angiographic procedures.
The affected devices are identified by Lot Nos. A3025038 and A3025051. A total of 435 units (87 boxes) have been distributed worldwide, including nationwide in the United States and 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.
Healthcare providers and facilities that have received these devices should stop using affected lots and contact Angiodynamics, Inc. directly. Patients who may have received treatment with affected devices should consult their healthcare providers.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- device-malfunction
- obstruction
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 (8)
- SOFT-VU CB2 4F X 65CM 038 NB 0SH
- Catalog No.: 10714011
- Product/UPN No.: H787107140115 (Box)
- H787107140110 (Pouch)
- UDI-DI: 25051684007877(Box)
- 15051684007870(Pouch)
- Lot No.: A3025038
- A3025051
Distribution
Distributed nationwide across the United States.
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