Soft-Vu Angiographic Catheter Recalled Due to Manufacturing Defect
Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter (Straight Art, Non-Braided) units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a medical device with a functional defect that could prevent proper insertion of guidewires, potentially compromising critical catheterization procedures. Class II with a significant device malfunction affecting clinical performance meets the Severe threshold.
Plain-English summary
Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter, Straight Art, Non-Braided (Catalog No. 10731401, Lot No. A2825042), with a total of 220 units affected (44 boxes). The recalled devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices 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.
Healthcare facilities and users who have received this product should stop use of the affected devices immediately and contact Angiodynamics, Inc. for further instructions regarding return or replacement.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- device-malfunction
- hub-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 (7)
- SOFT-VU STR ART 4F X 65CM 035 NB 0SH
- Catalog No.: 10731401
- Product/UPN No.: H787107314015 (Box)
- H787107314010 (Pouch)
- UDI-DI: 25051684009475(Box)
- 15051684009478(Pouch)
- Lot No.: A2825042
Distribution
Distributed nationwide across the United States.