Soft-Vu Angiographic Catheter, Kumpe, Non-Braided manufacturing defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe, Non-Braided devices 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. The defect presents a functional risk—guidewire passage failure could prevent proper catheter use during angiographic procedures—and the source text does not report any illnesses or injuries, meeting the criterion for a High severity score under the rubric.
Plain-English summary
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided (Catalog No. 10714014) due to a manufacturing defect affecting the inner diameter of the catheter hub. The defect may prevent an appropriately sized guidewire from passing through the hub, potentially compromising the device's intended function during angiographic procedures.
The recall affects 4,925 units (985 boxes) distributed worldwide, including throughout 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. The affected lot numbers are A2825033, A2825034, A2825132, A2825133, A3725048, and A3725049.
Patients and healthcare providers who have this device in stock or have received it should contact Angiodynamics, Inc. for instructions on how to proceed. Affected devices should not be used until guidance is received from the manufacturer.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
- Manufacturer
- Angiodynamics, Inc.
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 (12)
- SOFT-VU KMP 4F X 65CM 038 NB 0SH
- Catalog No.: 10714014
- Product/UPN No.: H787107140145 (Box)
- H787107140140 (Pouch)
- UDI-DI: 25051684007891(Box)
- 15051684007894(Pouch)
- Lot No.: A2825033
- A2825034
- A2825132
- A2825133
- A3725048
- A3725049
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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