Cordis S.M.A.R.T. Flex Vascular Stent System Recalled for Deployment Difficulty
Cordis Corporation is recalling 2,700 units of the S.M.A.R.T. Flex Vascular Stent System due to deployment difficulty. The recall affects foreign markets only.
What this means for you
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: The recall involves a medical device with a functional defect (deployment difficulty) that poses a risk of harm during a medical procedure, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cordis Corporation is recalling 2,700 units of the Cordis S.M.A.R.T. Flex Vascular Stent System. The recall is due to a reported issue with deployment difficulty. The affected units are distributed exclusively in foreign markets, including Argentina, Australia, Brazil, China, France, Germany, and the United Kingdom, among others.
The recall covers specific catalog numbers and lot numbers for stent sizes 5 x 200mm and 6 x 200mm, with catheter lengths of 80 cm and 120 cm. The source text does not specify reported injuries or illnesses associated with this defect. Consumers and healthcare providers in the affected countries should contact Cordis Corporation for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Cordis S.M.A.R.T. Flex Vascular Stent System
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Vascular Stent
- Hazard
- Affected units
- 2,700
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 (20)
- 1.) Catalog Numbers SF05200MV
- Size 5 x 200mm
- Catheter length 120 cm GTIN -Carton Level 20705032066829 Lot #'s: 34551
- 34552
- 34585
- 34586
- 34587
- 35009
- 35199
- 35228
- 35706
- 35741
- 35859
- 35860
- 36160
- 36275
- 36380
- 36666
- 36792
- 36859
Distribution
Distribution scope not specified by the agency.
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