Cordis PRECISE PRO RX Nitinol Stent System Recalled for Deployment Failure
Cordis Corporation is recalling PRECISE PRO RX Nitinol Stent Systems (Carotid) due to a risk of inability to deploy or partial deployment.
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 is classified as FDA Class II, and the hazard involves a risk of harm (deployment failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cordis Corporation is recalling the PRECISE (R) PRO RX Nitinol Stent System (Carotid) because of a potential defect that may result in the inability to deploy the stent or partial stent deployment. The recall covers 4,400 units in the United States and 3,100 units in foreign countries, including Japan, Taiwan, Thailand, and South Korea.
The affected products are identified by specific catalog numbers and lot numbers, including PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1020RXC, PC1030RXC, and PC1040RXC. The source text does not specify reported illnesses or injuries associated with this defect.
Healthcare providers and patients should check their inventory and patient records for these specific catalog and lot numbers. If a patient has received one of these stents, they should contact their healthcare provider for further evaluation and guidance.
The recalled product
- Product
- Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
- Manufacturer
- Cordis Corporation
- Hazard
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)
- Catalog Number: PC0520RXC
- Lot Numbers: 17298513
- 17340803
- Catalog Number: PC0530RXC
- Lot Numbers: 17283329
- 17286330
- 17333401 and 17376719
- Catalog Number: PC0540RXC
- Lot Numbers: 17295225
- 17312647
- 17337070 and 17366679
- Catalog Number: PC0620RXC
- Lot Numbers: 17256203
- 17264566
- 17282136 and 17382573
- Catalog Number: PC0630RXC
- Lot Numbers: 17255095
- 17264568
- 17287132
- 17294353
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Cordis Corporation 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.
See all 2 products in this recall →Related recalls
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