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.
What this means for you
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
Related recalls
Same manufacturer · Cordis Corporation
See all →- HighSMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement
FDA (Devices) · 2021-11-24
- HighSMART FLEX 6x120 Biliary Stent System Recalled for Potential Distal Tip Dislodgement
FDA (Devices) · 2021-11-24
- HighCordis SMART FLEX Biliary Stent System recalled for potential tip separation
FDA (Devices) · 2021-11-24
- HighCordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation
FDA (Devices) · 2021-11-24
- HighFDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk
FDA (Devices) · 2021-11-24
Same hazard · expired component
See all →- ModerateSperm separation media kits recalled for incorrect component lot
FDA (Devices) · 2024-02-14
- HighMedline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert
FDA (Devices) · 2024-02-07
- ModerateBlood Culture Bottle Kit Recalled for Expired Component Documentation Issue
FDA (Devices) · 2024-02-07
- HighMedline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates
FDA (Devices) · 2024-02-07
- HighMedline Blood Culture Collection Kit Recalled for Expired Bactec Component
FDA (Devices) · 2024-02-07