Soft-Vu Angiographic Catheter Omni Flush Non-Braided Defect Recall
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Omni Flush, Non-Braided) 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 involving a functional defect that could impair a critical procedural step (guidewire passage). No illnesses or injuries are reported in the source text, but the defect poses a direct risk of harm during interventional cardiology procedures.
Plain-English summary
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided (Catalog No. 10732301, Model SOFT-VU OF 4F X 65CM 035 NB 6SH). The affected devices contain a manufacturing defect that may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub.
A total of 4,840 units (484 boxes) have been distributed worldwide, including throughout the United States and internationally to Austria, Australia, Belgium, Canada, China, Chile, Curaçao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, and Thailand. The affected product lots are A2825022, A3025035, and A3025037.
If you have received or are using this catheter, discontinue use and contact Angiodynamics, Inc. for instructions on return or replacement of the product.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- device-malfunction
- guidewire-passage-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 (9)
- SOFT-VU OF 4F X 65CM 035 NB 6SH
- Catalog No.: 10732301
- Product/UPN No.: H787107323015 (Box)
- H787107323010 (Pouch)
- UDI-DI: 25051684009727(Box)
- 15051684009720(Pouch)
- Lot No.: A2825022
- A3025035
- A3025037
Distribution
Distributed nationwide across the United States.
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