SOFT-VU KUMPE Diagnostic Catheter Recalled for Mislabeled Inner Pouch
Angiodynamics recalls SOFT-VU KUMPE diagnostic catheters because inner pouch labels may show incorrect catheter length information, while the outer box label is accurate. 519 boxes distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling discrepancy rather than a product defect. The outer box label is accurate, and no illnesses or injuries have been reported. While incorrect catheter specifications could pose a risk, the availability of correct information on the outer label mitigates the immediate harm potential.
Plain-English summary
Angiodynamics, Inc. is recalling SOFT-VU KUMPE 5F X 40CM diagnostic catheters used for angiographic diagnosis. The recall involves 519 boxes with lot number A0424035, distributed nationwide in the United States.
The recall is due to a labeling error: the inner pouch label may contain specifications for a different catheter model, including incorrect catheter length information. The outer box label, which is the unit of sale, contains accurate information about the packaged device.
Healthcare providers and clinical staff using these catheters should be aware of this labeling discrepancy. When verifying product specifications, users should rely on the outer box label and the actual device rather than the inner pouch label alone.
The recalled product
- Product
- SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 519
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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