Cordis MAXI LD PTA Dilatation Catheter Recalled for Expired Component
Cordis Corporation is recalling 21 units of MAXI LD PTA Dilatation Catheters because they were manufactured using an expired inner body.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any illnesses, injuries, or deaths, and the hazard is a manufacturing deviation (expired component) rather than a known high-risk pathogen or structural defect causing immediate harm.
Plain-English summary
Cordis Corporation is recalling 21 units of the Cordis MAXI LD PTA Dilatation Catheter, a device used for cardiovascular procedures. The recall was initiated because the product was manufactured utilizing an expired inner body.
The affected units are identified by Catalog Number 4171460S, Lot Number 82169860, and an Expiry Date of 10/31/2020. These devices were distributed in the United States to facilities in Alabama, Arizona, Florida, Minnesota, and Missouri.
Healthcare providers and facilities that have received these units should stop using them immediately and contact Cordis Corporation for further instructions on the recall process.
The recalled product
- Product
- Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 21
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 (3)
- Catalog Number: 4171460S
- Lot Number: 82169860
- Expiry Date: 10/31/2020
Distribution
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