Cordis Corporation
Miami Lakes, FL
This page shows every FDA and USDA recall linked to Cordis Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
146
Total Recalls
2003
First Recall
2021
Most Recent
SMART FLEX 6x120 BIL, 120cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation o...
Oct 1, 2021
· Device
Active
SMART FLEX 6x150 BIL, 120cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation o...
Oct 1, 2021
· Device
Active
SMART FLEX 8x60 BIL, 80cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of...
Oct 1, 2021
· Device
Active
SMART FLEX 10x100 BIL, 120cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation...
Oct 1, 2021
· Device
Active
SMART FLEX 10x100 BIL, 80cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation o...
Oct 1, 2021
· Device
Active
SMART FLEX 9x60 BIL, 80cm
The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of...
Oct 1, 2021
· Device
Active
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Sep 15, 2021
· Device
Terminated
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Sep 15, 2021
· Device
Terminated
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Sep 15, 2021
· Device
Terminated
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
Sep 15, 2021
· Device
Terminated
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
Sep 15, 2021
· Device
Terminated
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Jul 19, 2021
· Device
Terminated
Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures req...
Jun 9, 2021
· Device
Terminated
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC063...
Feb 11, 2021
· Device
Completed
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Feb 28, 2020
· Device
Terminated
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Oct 4, 2019
· Device
Terminated
Cordis Vista Brite Tip & Androit Guiding Catheters
Product Usage:
The guiding catheter is intended for use fo...
Feb 7, 2019
· Device
Terminated
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral...
Sep 5, 2018
· Device
Terminated
Cordis S.M.A.R.T. Flex Biliary Stent System
Product Usage:
Is indicated for use in the palliation of malignan...
Nov 15, 2017
· Device
Terminated
Cordis S.M.A.R.T. Flex Vascular Stent System
Feb 16, 2017
· Device
Terminated
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
May 4, 2016
· Device
Terminated
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
May 4, 2016
· Device
Terminated
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM
The product includes a Catheter Sheath Introducer (CSI) and...
Mar 15, 2016
· Device
Terminated
RenLane Renal Denervation Catheter; Cat No.: D135601.
Used in adults patients (>18 years) with drug resistant...
Aug 18, 2015
· Device
Terminated
Cordis POWERFLEX PRO PTA Dilatation Catheter
Intended to dilate stenoses in iliac, femoral, ilio-femoral, pop...
Jan 16, 2015
· Device
Terminated
Cordis EMPIRA NC RX PTCA Dilatation Catheter
Aug 28, 2014
· Device
Terminated
Cordis EMPIRA RX PTCA Dilatation Catheter
Aug 28, 2014
· Device
Terminated
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Jun 11, 2014
· Device
Terminated
Cordis OPTEASE Vena Cava Filter
Is indicated for use in the prevention of recurrent pulmonary embolism (PE) v...
Oct 25, 2013
· Device
Terminated
Cordis ADROIT 6F Guiding Catheter
Product Usage:
For intravascular introduction of interventional and/or diag...
Oct 1, 2013
· Device
Terminated
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Fi...
Aug 7, 2013
· Device
Terminated
FLEXSTENT Femoropopliteal Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Femoropopliteal SES...
Jun 6, 2013
· Device
Terminated
FLEXSTENT Biliary Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Biliary SES product is indic...
Jun 6, 2013
· Device
Terminated
FLEXSTENT Biliary Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Biliary SES product is indic...
Jun 6, 2013
· Device
Terminated
FLEXSTENT Femoropopliteal Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Femoropopliteal SES...
Jun 6, 2013
· Device
Terminated
FLEXSTENT Femoropopliteal Self-Expanding Stent System.
Product Usage:
The FSS FLEXSTENT Femoropopliteal SES...
Jun 6, 2013
· Device
Terminated
Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX...
Jan 25, 2013
· Device
Terminated
Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter...
Sep 21, 2012
· Device
Terminated
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter L...
Sep 21, 2012
· Device
Terminated
Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No....
May 10, 2012
· Device
Terminated
Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***...
May 10, 2012
· Device
Terminated
S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the i...
Feb 15, 2012
· Device
Terminated
S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by cathe...
Feb 15, 2012
· Device
Terminated
SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)**...
Nov 17, 2011
· Device
Terminated
SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)**...
Nov 17, 2011
· Device
Terminated
Cordis, AVANTI+ Introducer, STERILE EO, For one use only.
Catalog 402656X Lot # 15076369.
Catalog 504606...
Apr 20, 2010
· Device
Terminated
Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire D...
Jan 13, 2010
· Device
Terminated
Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway,...
Nov 5, 2009
· Device
Terminated
MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular
Intended to be used as a mechani...
Dec 30, 2008
· Device
Terminated
Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indica...
Oct 31, 2008
· Device
Terminated