US Endovascular Recalls Ebony PTA Catheters Due to Kinking Risk
US Endovascular is recalling 843 Ebony PTA catheters because they may kink during use, rendering them unusable.
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: The recall is classified as FDA Class II. The hazard is that the device may kink and become unusable, which is a functional defect without reported injuries or hospitalizations, fitting the Moderate severity criteria.
Plain-English summary
US Endovascular is recalling 843 units of the USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. The recall was initiated because the product may kink during use, which renders the product unusable.
The affected catheters were distributed in the United States to the states of Arkansas, California, Florida, Louisiana, Missouri, Michigan, Mississippi, New York, Tennessee, and Texas. The recall covers specific lot numbers listed in the agency's documentation.
Healthcare providers and consumers should stop using the affected catheters and contact US Endovascular for further instructions or a replacement.
The recalled product
- Product
- USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
- Manufacturer
- Us Endovascular
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 843
Distribution
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