Devices

Device Recall Cordis PRECIS (R) PRO Rx Nitinol Stent System

Model / Serial
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, 17306044, 17308314, 17328366, 17337071, 17364507, 17388949 and 17392573; Catalog Number: PC0640RXC, Lot Numbers: 17249849, 17264995, 17283330, 17296211, 17331381, 17356085, 17364567, 17370803 and 17392574; Catalog Number: PC0720RXC, Lot Numbers: 17249850 and 17260987; Catalog Number: PC0730RXC, Lot Numbers: 17256214, 17264569, 17276754, 17290641, 17322268,17332269, 17341779, 17347010, 17357107, 17361603, 17381650 and 17386230; Catalog Number: PC0740RXC, Lot Numbers: 17250948, 17253599, 17264571, 17282140, 17287345, 17295226, 17308316, 17322270, 17325372, 17331383, 17335082, 17344455, 17351475, 17361605, 17371407 and 17378613; Catalog Number: PC0820RXC, Lot Numbers: 17260988 and 17347026; Catalog Number: PC0830RXC, Lot Numbers: 17250952, 17256217, 17259977, 17265886, 17270630, 17280875, 17291876, 17294239, 17323767, 17328144, 17335802, 17340809,17349810, 17357109, 17360669, 17364569, 17369477,17376721, 17379881, 17381652 and 17388950; Catalog Number: PC0840RXC, Lot Numbers: 17247325, 17251834, 17259051, 17264572, 17276782, 17287346, 17296212, 17306048,17321489, 17325375, 17328145,17335084, 17335085, 17346758, 17346759, 17349811, 17356086, 17360672, 17364570, 17370806 and 17379882; Catalog Number: PC0920RXC, Lot Numbers: 17269319 and 17388951; Catalog Number: PC0930RXC, Lot Numbers: 17251837, 17274483, 17290643, 17298514, 17312648, 17313248, 17349018 , 17357110, 17361606, 17366682 and 17393271; Catalog Number: PC0940RXC, Lot Number: 17260989, 17264998, 17270632, 17272818, 17280877, 17307877, 17312649, 17319031, 17319032, 17329303, 17339531, 17349019, 17354593, 17386232, 17387886 and 17397607. Catalog Number: PC1020RXC, Lot Number: 17314385; Catalog Number: PC1030RXC, Lot Numbers: 17251838, 17268217, 17274485, 17283332, 17287135, 17313250, 17329304, 17344458 and 17397609; Catalog Number: PC1040RXC, Lot 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.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
Product Description
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
Manufacturer
Cordis Corporation
1 Event
- Recall of Device Recall Cordis PRECIS (R) PRO Rx Nitinol Stent System

Manufacturer

Cordis Corporation

Manufacturer Address
Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
Manufacturer Parent Company (2017)
Cardinal Health
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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