Soft-Vu Angiographic Catheter Angiodynamics Guidewire Passage Defect
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The catheters were distributed worldwide including the US.
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: FDA Class II medical device recall where the manufacturing defect creates a risk of harm (obstruction of guidewire passage) that could compromise the device's intended function during a catheterization procedure. No reported illnesses or injuries are mentioned in the source.
Plain-English summary
Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter, Berenstein, Non-Braided (Catalog No. 10714009, SOFT-VU BER 4F X 65CM 038 NB 0SH) with Product/UPN Nos. H787107140095 (Box) and H787107140090 (Pouch). Approximately 1520 units across 304 boxes are affected.
The recalled catheters contain a manufacturing defect that may prevent an appropriately sized guidewire from passing through the inner diameter of the catheter hub.
The affected products were distributed worldwide to the US and 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 A2825134, A2825153, and A3825063.
Patients or healthcare providers who have the affected devices should contact Angiodynamics, Inc. for further instructions.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- guidewire-obstruction
- manufacturing-defect
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 (9)
- SOFT-VU BER 4F X 65CM 038 NB 0SH
- Catalog No.: 10714009
- Product/UPN No.: H787107140095 (Box)
- H787107140090 (Pouch)
- UDI-DI: 25051684007853(Box)
- 15051684007856(Pouch)
- Lot No.: A2825134
- A2825153
- A3825063
Distribution
Distributed nationwide across the United States.
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