Cordis Precise Pro RX Carotid Stent Recall for Tip Separation
Cordis is recalling Precise Pro RX Carotid Stent implant systems because the distal tip may separate from the lumen wire.
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 structural defect (tip separation) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cordis Corporation is recalling the Precise Pro RX Carotid Stent implant system. The recall involves 18,218 units distributed in the United States (excluding Montana and New Mexico) and Taiwan.
The recall was initiated because the distal tip of the stent may become separated from the lumen wire in specific lots. The affected product codes and lot numbers are detailed in the official recall documentation.
Healthcare providers and patients who have received these specific stent systems should contact Cordis Corporation for further instructions on the recall and potential replacement or repair options.
The recalled product
- Product
- PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
- Manufacturer
- Cordis Corporation
- Affected units
- 18,218
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. PC0520RXC
- Lot Numbers: 17917082
- 17925698
- 17945241
- 17946961 2. PC0530RXC
- Lot Numbers: 17907242
- 17915157
- 17931757
- 17936915
- 17940306
- 17945490
- 17950283
- 17952939 3. PC0540RXC
- Lot Numbers: 17907243
- 17911879
- 17920422
- 17931758
- 17942800
- 17945242
- 17947078
Distribution
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