Soft-Vu Angiographic Catheter Kumpe Non-Braided manufacturing defect recall
Angiodynamics is recalling Soft-Vu Angiographic Catheter Kumpe units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device with a manufacturing defect that prevents proper guidewire passage through the catheter hub, posing a risk of harm during an invasive medical procedure. The source text does not report any illnesses or injuries, making this a risk-of-harm scenario where injury has not yet been reported, fitting the rubric criterion for a score of 3.
Plain-English summary
Angiodynamics, Inc. is recalling certain Soft-Vu Angiographic Catheter, Kumpe, Non-Braided units (Catalog No. 10710013; Lots A3625012 and A3825055) due to a manufacturing defect in the catheter hub. The defect may prevent an appropriately sized guidewire from passing through the inner diameter of the catheter hub, potentially compromising the device's intended use during angiographic procedures.
The affected devices were distributed worldwide, including throughout the United States 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. A total of 785 units (157 boxes) are affected.
Healthcare providers and patients who have received this product should stop use and contact Angiodynamics, Inc. immediately for instructions on device replacement or return. Affected users should verify lot numbers on their product packaging against the recalled lots listed above.
The recalled product
- Product
- Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (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 (8)
- SOFT-VU KMP 4F X 40CM 038 NB 0SH
- Catalog No.: 10710013
- UDI-DI: 25051684007440 (Box)
- 15051684007443 (Pouch)
- Product/UPN No.: H787107100135 (Box)
- H787107100130 (Pouch)
- Lot No.: A3625012
- A3825055
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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