FDA Device Recalls

Recalls / Firms / Cordis Corporation

Cordis Corporation

147 FDA device recalls on record.

DateClassProductReason
2021-10-01SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the pa
2021-10-01SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the p
2021-10-01SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the pall
2021-10-01SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the pa
2021-10-01SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the pall
2021-10-01SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the pa
2021-07-21Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
2021-07-21Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
2021-07-21Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
2021-07-21Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
2021-07-21Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
2021-07-19Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
2021-06-09Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous proc
2021-02-11PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620
2020-01-08Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
2019-10-04Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
2019-02-07Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended
2018-09-05Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in ilia
2017-11-15Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation o
2017-02-16Cordis S.M.A.R.T. Flex Vascular Stent System
2016-05-04Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
2016-05-04Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
2015-12-31CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer
2014-12-22Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-fe
2014-06-23Cordis EMPIRA NC RX PTCA Dilatation Catheter
2014-06-23Cordis EMPIRA RX PTCA Dilatation Catheter
2014-04-15RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug
2013-09-27Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embol
2013-08-12Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional a
2013-04-23FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopl
2013-04-23FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES produc
2013-04-23FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES produc
2013-04-23FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopl
2013-04-23FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopl
2013-03-29Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Ve
2013-02-05Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
2012-10-29Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX6
2012-04-09Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.
2012-04-09Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***
2012-01-31S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter
2012-01-31S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivere
2011-11-21SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (
2011-11-21SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (
2011-01-31Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable
2011-01-31Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usabl
2010-01-28Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Cata
2009-10-15Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valle
2009-08-25Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, G
2008-08-20Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter
2008-06-30MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to be used as
2008-03-10CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in Mexico. I
2008-01-14CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 1.50 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011515S, Distribu
2008-01-14CORDIS "Dura Star" 4.00 x 10 Dilatation Catheter, Catalog # 70110400, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 2.75 x 30 Dilatation Catheter, Catalog # 70130275, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.00 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011020S, Distribu
2008-01-14CORDIS "Fire Star" 2.50 x 20 Dilatation Catheter, Catalog # 80120250, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 2.75 x 10 Dilatation Catheter, Catalog # 80110275, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.25 x 15 Dilatation Catheter, Catalog # 80115225, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 3.25 x 20 Dilatation Catheter, Catalog # 80120325, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 2.50 x 30 Dilatation Catheter, Catalog # 80130250, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 3.25 x 10 Dilatation Catheter, Catalog # 80110325, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 2.50 x 20 Dilatation Catheter, Catalog # 70120250, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 2.25 x 25 Dilatation Catheter, Catalog # 70125225, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 3.50 x 10 Dilatation Catheter, Catalog # 80110350, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.50 x 15 Dilatation Catheter, Catalog # 70115350, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 2.75 x 15 Dilatation Catheter, Catalog # 70115275, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 2.50 x 10 Dilatation Catheter, Catalog # 70110250, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.25 x 10 Dilatation Catheter, Catalog # 80110225, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 4.00 x 15 Dilatation Catheter, Catalog # 70115400, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.25 x 25 Dilatation Catheter, Catalog # 70125325, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.25 x 15 Dilatation Catheter, Catalog # 70115325, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 1.50 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012015S, Distribut
2008-01-14CORDIS "Dura Star" 3.75 x 25 Dilatation Catheter, Catalog # 70125375, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 2.75 x 25 Dilatation Catheter, Catalog # 70125275, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.00 x 10 Dilatation Catheter, Catalog # 70110300, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 4.00 x 30 Dilatation Catheter, Catalog # 70130400, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 2.75 x 10 Dilatation Catheter, Catalog # :70110275, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 3.50 x 15 Dilatation Catheter, Catalog # 80115350, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 2.75 x 15 Dilatation Catheter, Catalog # 80115275, Distributed by Cordis Corpora
2008-01-14CORDIS "Dura Star" 3.25 x 30 Dilatation Catheter, Catalog # 70130325, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.75 x 10 Dilatation Catheter, Catalog # 70110375, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.00 x 10, Dual Marker Band, Dilatation Catheter, Catalog # 8011020D, Distributed
2008-01-14CORDIS "Fire Star" 3.00 x 10 Dilatation Catheter, Catalog # 80110300, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.50 x 10 Dilatation Catheter, Catalog # 80110250, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 3.25 x 30 Dilatation Catheter, Catalog # 80130325, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 3.25 x 15 Dilatation Catheter, Catalog # 80115325, Distributed by Cordis Corpora
2008-01-14CORDIS "Dura Star" 4.00 x 25 Dilatation Catheter, Catalog # 70125400, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.00 x 30, Dual Marker Band, Dilatation Catheter, Catalog # 8013020D, Distributed
2008-01-14CORDIS "Dura Star" 3.75 x 20 Dilatation Catheter, Catalog # 70120375, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 3.00 x 20 Dilatation Catheter, Catalog # 80120300, Distributed by Cordis Corpora
2008-01-14CORDIS "Dura Star" 2.50 x 25 Dilatation Catheter, Catalog # 70125250, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 2.50 x 15 Dilatation Catheter, Catalog # 70115250, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.00 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012020S, Distribut
2008-01-14CORDIS "Fire Star" 2.50 x 15 Dilatation Catheter, Catalog # 80115250, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 3.50 x 20 Dilatation Catheter, Catalog # 80120350, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 1.50 x 20, Dual Marker Band , Dilatation Catheter, Catalog # 8012015D, Distribute
2008-01-14CORDIS "Dura Star" 2.25 x 15 Dilatation Catheter, Catalog # 70115225, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 1.50 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011015S, Distribut
2008-01-14CORDIS "Dura Star" 2.25 x 30 Dilatation Catheter, Catalog # 70130225, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 3.50 x 30 Dilatation Catheter, Catalog # 80130350, Distributed by Cordis Corpora
2008-01-14CORDIS "Dura Star" 2.25 x 20 Dilatation Catheter, Catalog # 70120225, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.25 x 20 Dilatation Catheter, Catalog # 80120225, Distributed by Cordis Corpora
2008-01-14CORDIS "Dura Star" 2.25 x 10 Dilatation Catheter, Catalog # 70110225, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.50 x 20 Dilatation Catheter, Catalog # 70120350, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.75 x 15 Dilatation Catheter, Catalog # 70115375, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.25 x 30 Dilatation Catheter, Catalog # 80130225, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 2.00 x 30, Single Marker Band, Dilatation Catheter, Catalog # 8013020S, Distribu
2008-01-14CORDIS "Fire Star" 2.00 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011520D, Distribute
2008-01-14CORDIS "Dura Star" 3.50 x 25 Dilatation Catheter, Catalog # 70125350, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 3.00 x 30 Dilatation Catheter, Catalog # 80130300, Distributed by Cordis Corpora
2008-01-14CORDIS "Dura Star" 3.00 x 20 Dilatation Catheter, Catalog # 70120300, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 2.50 x 30 Dilatation Catheter, Catalog # 70130250, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 1.50 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011515D,Distributed
2008-01-14CORDIS "Dura Star" 3.25 x 10 Dilatation Catheter, Catalog # 70110325, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.00 x 20, Dual Marker Band, Dilatation Catheter, Catalog # 8012020D, Distributed
2008-01-14CORDIS "Dura Star" 4.00 x 20 Dilatation Catheter, Catalog # 70120400, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.00 x 25 Dilatation Catheter, Catalog # 70125300, Distributed by Cordis Corporat
2008-01-14CORDIS "Fire Star" 2.75 x 30 Dilatation Catheter, Catalog # 80130275, Distributed by Cordis Corpora
2008-01-14CORDIS "Fire Star" 1.50 x 10, Dual Maker Band, Dilatation Catheter, Catalog # 8011015D, Distributed
2008-01-14CORDIS "Fire Star" 2.00 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011520S, Distribut
2008-01-14CORDIS "Fire Star" 2.75 x 20 Dilatation Catheter, Catalog # 80120275, Distributed by Cordis Corpora
2008-01-14CORDIS "Dura Star" 2.75 x 20 Dilatation Catheter, Catalog # 70120275, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.50 x 30 Dilatation Catheter, Catalog # 70130350, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.25 x 20 Dilatation Catheter, Catalog # 70120325, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.00 x 30 Dilatation Catheter, Catalog # 70130300, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.00 x 15 Dilatation Catheter, Catalog # 70115300, Distributed by Cordis Corporat
2008-01-14CORDIS "Dura Star" 3.75 x 30 Dilatation Catheter, Catalog # 70130375, Distributed by Cordis Corporat
2006-07-21CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company E
2006-07-21CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires,Cordis a Johnson Johnson Company ,EN
2006-07-21CORDIS SV-8 Steerable Guidewire, 180 cm. , 5 Steerable Guidewires, Cordis a Johnson Johnson Company,
2006-07-21CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company,
2006-06-26Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, 534617T,
2005-05-11Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis
2005-01-12Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
2004-12-07VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
2004-11-18Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cyph
2004-05-05Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide ga
2004-01-13This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer cart
2003-09-26The device is in a tyvek pouch and is labeled in part: Aviator Peripheral Dilatation Catheter REF C
2003-09-26This device is labeled as Sterile and is packaged in a Tyvek pouch with the following labeling: PALM
2003-08-29Cordis Biopsy Forceps 7F 104 cm Standard, Product Number 504300L
2003-08-29CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L
2003-05-05Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only).
2003-02-03The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIO
2002-11-07Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', C