Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
FDA Device Recall #Z-1946-2016 — Class II — May 4, 2016
Recall Summary
| Recall Number | Z-1946-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 4, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cordis Corporation |
| Location | Miami Lakes, FL |
| Product Type | Devices |
| Quantity | 4,400 units in US and 3,100 units in Foreign Countries |
Product Description
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
Reason for Recall
Inability to deploy the stent or partial stent deployment.
Distribution Pattern
NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
Lot / 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.
Other Recalls from Cordis Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0221-2022 | Class II | SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ F... | Oct 1, 2021 |
| Z-0216-2022 | Class II | SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex... | Oct 1, 2021 |
| Z-0220-2022 | Class II | SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Fl... | Oct 1, 2021 |
| Z-0218-2022 | Class II | SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Fl... | Oct 1, 2021 |
| Z-0219-2022 | Class II | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex... | Oct 1, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.