Reported Jun 22, 2016 · Terminated
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
Cordis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
- Lot codes and dates
17 of 17 products
Products covered by this recall Model / number Product as published PC0520RXCLot Numbers: 17298513, 17340803 PC0530RXCLot Numbers: 17283329, 17286330, 17333401 and 17376719 PC0540RXCLot Numbers: 17295225 , 17312647, 17337070 and 17366679 PC0620RXCLot Numbers: 17256203, 17264566, 17282136 and 17382573 PC0630RXCLot Numbers: 17255095, 17264568, 17287132, 17294353, 17306044, 17308314, 17328366, 17337071, 17364507, 17388949 and 17392573 PC0640RXCLot Numbers: 17249849, 17264995, 17283330, 17296211, 17331381, 17356085, 17364567, 17370803 and 17392574 PC0720RXCLot Numbers: 17249850 and 17260987 PC0730RXCLot Numbers: 17256214, 17264569, 17276754, 17290641, 17322268,17332269, 17341779, 17347010, 17357107, 17361603, 17381650 and 17386230 PC0740RXCLot Numbers: 17250948, 17253599, 17264571, 17282140, 17287345, 17295226, 17308316, 17322270, 17325372, 17331383, 17335082, 17344455, 17351475, 17361605, 17371407 and 17378613 PC0820RXCLot Numbers: 17260988 and 17347026 PC0830RXCLot Numbers: 17250952, 17256217, 17259977, 17265886, 17270630, 17280875, 17291876, 17294239, 17323767, 17328144, 17335802, 17340809,17349810, 17357109, 17360669, 17364569, 17369477,17376721, 17379881, 17381652 and 17388950 PC0840RXCLot Numbers: 17247325, 17251834, 17259051, 17264572, 17276782, 17287346, 17296212, 17306048,17321489, 17325375, 17328145,17335084, 17335085, 17346758, 17346759, 17349811, 17356086, 17360672, 17364570, 17370806 and 17379882 PC0920RXCLot Numbers: 17269319 and 17388951 PC0930RXCLot Numbers: 17251837, 17274483, 17290643, 17298514, 17312648, 17313248, 17349018 , 17357110, 17361606, 17366682 and 17393271 PC1020RXCCatalog Number: PC0940RXC, Lot Number: 17260989, 17264998, 17270632, 17272818, 17280877, 17307877, 17312649, 17319031, 17319032, 17329303, 17339531, 17349019, 17354593, 17386232, 17387886 and 17397607. , Lot Number: 17314385 PC1030RXCLot Numbers: 17251838, 17268217, 17274485, 17283332, 17287135, 17313250, 17329304, 17344458 and 17397609 PC1040RXCLot Numbers: 17253601, 17259979, 17268219, 17282144, 17286334, 17290644, 17294357, 17298515, 17298516, 17310830, 17313251, 17316969, 17319035, 17319036, 17329305, 17329306, 17349020, 17354594, 17358957, 17364509, 17369479, 17375323, 17379887, 17388953, 17390538 and 17394539. - Amount recalled
- 4,400 units in US and 3,100 units in Foreign Countries
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Inability to deploy the stent or partial stent deployment.
This product could cause temporary or reversible health problems — stop using it.
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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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