Cordis Corporation

FDA Regulatory Profile

Summary

Total Recalls
39 (7 Class I)
510(k) Clearances
13
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0218-2022Class IISMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the pOctober 1, 2021
Z-0219-2022Class IISMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palOctober 1, 2021
Z-0217-2022Class IISMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the pOctober 1, 2021
Z-0216-2022Class IISMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palOctober 1, 2021
Z-0220-2022Class IISMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the pOctober 1, 2021
Z-0221-2022Class IISMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the October 1, 2021
Z-2432-2021Class ICordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598CJuly 21, 2021
Z-2428-2021Class ICordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MBJuly 21, 2021
Z-2431-2021Class ICordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598BJuly 21, 2021
Z-2430-2021Class ICordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598AJuly 21, 2021
Z-2429-2021Class ICordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MBJuly 21, 2021
Z-2235-2021Class IICordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010XJuly 19, 2021
Z-2079-2021Class IIAvanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous proJune 9, 2021
Z-1257-2021Class IPRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620February 11, 2021
Z-1477-2020Class IICordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020SJanuary 8, 2020
Z-0250-2020Class IICordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.October 4, 2019
Z-1198-2019Class IIICordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intendFebruary 7, 2019
Z-0390-2019Class IICordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliaSeptember 5, 2018
Z-0324-2018Class IICordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliatioNovember 15, 2017
Z-1826-2017Class IICordis S.M.A.R.T. Flex Vascular Stent SystemFebruary 16, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireApril 6, 2022
K212977SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsFebruary 17, 2022
K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterApril 23, 2021
K202167Brite Tip Radianz Guiding SheathFebruary 26, 2021
K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterOctober 9, 2020
K201333SABER .035 PTA Dilatation CatheterSeptember 11, 2020
K181592RAIN Sheath TransradialAugust 15, 2018
K180081RAILWAY Sheathless Access SystemApril 18, 2018
K143412ADROIT Guiding CatheterJanuary 14, 2015
K133843SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETERJune 27, 2014
K121442POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERJune 14, 2012
K041796PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEMAugust 3, 2004
K034050CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C22March 22, 2004