Reported Mar 24, 2021 · Completed
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC,…
Cordis Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis Corporation · 14201 NW 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- PRECISE PRO RX CAROTID STENT implant system
- Product Codes
PC0520RXCPC0530RXCPC0540RXCPC0620RXCPC0630RXCPC0640RXCPC0720RXCPC0730RXCPC0740RXCPC0820RXCPC0830RXCPC0840RXCPC0920RXCPC0930RXCPC0940RXCPC1030RXCPC1040RXC
- Lot codes and dates
16 of 16 products
Products covered by this recall # Product as published 1 Lot Numbers: 17907242, 17915157, 17931757, 17936915, 17940306, 17945490, 17950283, 17952939 3. PC0540RXC 2 Lot Numbers: 17907243, 17911879, 17920422, 17931758, 17942800, 17945242, 17947078, 17950284, 17955963, 17960311 4. PC0620RXC 3 Lot Numbers: 17917084, 17920423, 17931102, 17949017, 17955964 5. PC0630RXC 4 Lot Numbers: 17910548, 17914196, 17915158, 17921807, 17937805, 17939529, 17945243, 17945883, 17949018, 17957289 6. PC0640RXC 5 Lot Numbers: 17903563, 17908608, 17912281, 17916478, 17928282, 17934629, 17936243, 17939530, 17946675, 17950285, 17958864, 17961560 7. PC0720RXC 6 Lot Numbers: 17929124, 17933386 8. PC0730RXC 7 Lot Numbers: 17909814, 17916479, 17925699, 17929770, 17935168, 17940238, 17941419, 17949346, 17951255, 17951944, 17954156, 17959599 9. PC0740RXC 8 Lot Numbers: 17905295, 17915162, 17920425, 17922174, 17926320, 17935169, 17936920, 17937807, 17940240, 17941874, 17941875, 17956888, 17959601, 17962539 10. PC0820RXC 9 Lot Numbers: 17905297, 17919723, 17942803, 17945491 11. PC0830RXC 10 Lot Numbers: 17910553, 17916481, 17919724, 17928285, 17931762, 17934630, 17936244, 17939531, 17945884, 17945885, 17949962, 17955967, 17959602 12. PC0840RXC 11 Lot Numbers: 17904654, 17907246, 17910556, 17912285, 17913915, 17918979, 17918980, 17920427, 17921809, 17924451, 17926321, 17928286, 17929771, 17931763, 17933387, 17935170, 17936245, 17936922, 17936923, 17941421, 17941422, 17941876, 17941877, 17947267, 17947268, 17948772, 17949964, 17951256, 17958217, 17959603, 17961226 13. PC0920RXC 12 Lot Numbers: 17949965 14. PC0930RXC 13 Lot Numbers: 17906531, 17914902, 17929126, 17934632, 17941424, 17945244, 17946676, 17946963, 17960312 15. PC0940RXC 14 Lot Numbers: 17907250, 17912290, 17914198, 17916482, 17917085, 17919725, 17928287, 17931103, 17935173, 17936247, 17939532, 17940242, 17945886, 17950287, 17955668 16. PC1030RXC 15 Lot Numbers: 17911881, 17913484, 17918070, 17934633, 17940243, 17947080 17. PC1040RXC 16 Lot Numbers: 17913485, 17917086, 17917087, 17917088, 17920429, 17927599, 17929128, 17931104, 17934634, 17935176, 17936248, 17940244, 17940245 - Amount recalled
- 18218 units
Where it was sold
Why it was recalled
Stop using this product now
Distal tip may become separated from the lumen wire in specific lots.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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