Recalls / —
—#146277
Product
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
- FDA product code
- NIM — Stent, Carotid
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P030047
- Affected lot / code info
- 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.
Why it was recalled
Inability to deploy the stent or partial stent deployment.
Root cause (FDA determination)
Component design/selection
Action the firm took
Cordis sent an Urgent Medical Device Recall (Removal) letter dated May 4, 2016, to all affected customers. Action to be taken by the customer: 1) Immediately check your inventory to confirm whether you have any units from affected lots in your possession. Identify and set aside any units from the affected lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 2) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. Note that you will receive multiple letters and Acknowledgement Forms if your facility received affected product at both a legacy Ship-To account number and a Cardinal Health Ship To account number at the same address. In that scenario, please sign and return both forms. 3) Return all affected products to the address listed on the form, with reference to Return Authorization Number ( i.e. RA #)#which is listed on the form. Replacement devices will be shipped after the affected product is returned. Consigned Inventory will also be replaced after the product is returned and an analysis of SKU mix needed to properly support the customer is conducted. 4) Share this letter with others in your facility who need to be made aware of this recall, including the areas in some facilities where these products are frequently used (see list above) Contact any other facilities that have been provided with units of affected lots. Maintain awareness of this notice until all affected product has been returned to Cordis. 5) Keep a copy of this notice with any affected product until returned. For questions related to assistance returning product or billing concerns or questions please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00AM to 8:00 PM EDT.
Recalling firm
- Firm
- Cordis Corporation
- Address
- 14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802
Distribution
- Distribution pattern
- NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
Timeline
- Recall initiated
- 2016-05-04
- Terminated
- 2019-07-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #146277. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.