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Recall Observatory FDA recall evidence

Device product

Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)

Z-1946-2016

May 04, 2016

Class II

Product summary

Firm
Cordis Corporation
Event
Event 74097
Status
Terminated
Classification
Class II
Quantity
4,400 units in US and 3,100 units in Foreign Countries
Official record key
device-enforcement:Z-1946-2016

Official wording

Reason: Inability to deploy the stent or partial stent deployment.

Code information: 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.

Distribution pattern: NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inability to deploy the stent or partial stent deployment.