Data / Medical devices / United States / Cordis US Corp.
Cordis US Corp.: FDA-registered device maker in Miami Lakes, FL, United States, 79 510(k) clearances and 7 PMA approvals
Cordis US Corp. is registered with the FDA (registration 1016427) in Miami Lakes, FL, United States. It lists 22 device types. The FDA files 79 510(k) clearances and 7 PMA approvals under its listings, the newest dated June 28, 2024. 52 recall events name it as the recalling firm (5 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1016427
- Address
- 14201 N.W. 60TH Ave., Miami Lakes, FL, United States, 33014
- Owner or operator
- Cordis US Corp. (1016427)
- Roles
- Complaint file establishment, Manufacturer for export, Specification developer
- First device listed
- March 2, 2006
- Registered through
- 2027
- Brand names listed
- 4F & 5F Nylex Diagnostic Catheters, 4F & 5F Tempo Diagnostic Catheters, 4F Infiniti Diagnostic Catheter, 4F Super Torque Diagnostic Catheter, 4F Tempo Aqua Diagnostic Catheter, 5.2F Super Torque Plus Diagnostic Catheter, 5F & 6F Infiniti Diagnostic Catheter, 5F ADROIT Guiding Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiac Catheterization Kit | OES | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cardiovascular Procedure Kit | OEZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter For Crossing Total Occlusions | PDU | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Complaint file establishment | accessdata.fda.gov |
| Device, Biopsy, Endomyocardial | DWZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Hemostasis, Vascular | MGB | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dilator, Esophageal | KNQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Filter, Intravascular, Cardiovascular | DTK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pulmonary Stent | QWC | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stent, Carotid | NIM | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stent, Iliac | NIO | 3 | Complaint file establishment, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Stent, Renal | NIN | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stent, Superficial Femoral Artery | NIP | 3 | Complaint file establishment, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Complaint file establishment, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Temporary Carotid Catheter For Embolic Capture | NTE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 28, 2024 | K233637 | Cordis BRITECROSS Support Catheter | DQY | Substantially Equivalent | Cordis US Corp | accessdata.fda.gov |
| November 21, 2023 | K232573 | INFINITI Ambi Angiographic Catheter | DQO | Substantially Equivalent | Cordis US Corp | accessdata.fda.gov |
| October 11, 2023 | K232578 | VASSALLO GT 018 G12; VASSALLO GT 018 G30 | DQX | Substantially Equivalent | Filmec Co. , Ltd. | accessdata.fda.gov |
| October 11, 2023 | K232574 | VASSALLO GT Crossing14 | DQX | Substantially Equivalent | Filmec Co. , Ltd. | accessdata.fda.gov |
| April 24, 2023 | K230704 | RAIN Sheath Tibial Pedal Introducer | DYB | Substantially Equivalent | Cordis US Corp | accessdata.fda.gov |
| March 9, 2023 | K223432 | Vassallo GT 018 Hybrid | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| October 26, 2022 | K222631 | VASSALLO GT EXT | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| August 22, 2022 | K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter | LIT | Substantially Equivalent | Cordis US Corp | accessdata.fda.gov |
| June 30, 2022 | K213949 | VASSALLO GT 018 Floppy | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| April 6, 2022 | K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | NTE | Substantially Equivalent | Cordis Corporation | accessdata.fda.gov |
| February 17, 2022 | K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | DQO | Substantially Equivalent | Cordis Corporation | accessdata.fda.gov |
| May 4, 2021 | K203529 | VASSALLO GT Hybrid | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| April 23, 2021 | K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | LIT | Substantially Equivalent | Cordis Corporation | accessdata.fda.gov |
| April 21, 2021 | K203533 | VASSALLO GT | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| February 26, 2021 | K202167 | Brite Tip Radianz Guiding Sheath | DYB | Substantially Equivalent | Cordis Corporation | accessdata.fda.gov |
| October 9, 2020 | K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter | LIT | Substantially Equivalent | Cordis Corporation | accessdata.fda.gov |
| August 15, 2018 | K181592 | RAIN Sheath Transradial | DYB | Substantially Equivalent | Cordis Corporation | accessdata.fda.gov |
| August 8, 2018 | K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters | DQO | Substantially Equivalent | Cordis, A Cardinal Health Company | accessdata.fda.gov |
| April 18, 2018 | K180081 | RAILWAY Sheathless Access System | DYB | Substantially Equivalent | Cordis Corporation | accessdata.fda.gov |
| July 31, 2015 | K151363 | Zephyr Vascular Compression Device | DXC | Substantially Equivalent | Advanced Vascular Dynamics | accessdata.fda.gov |
| May 19, 2015 | K150187 | ELITECROSS Support Catheter | PDU | Substantially Equivalent | Cordis Corporation, A Johnson & Johnson Company | accessdata.fda.gov |
| April 29, 2015 | K150836 | OUTBACK Elite Re-Entry Catheter | PDU | Substantially Equivalent | Cordis Corporation, A Johnson & Johnson Co. | accessdata.fda.gov |
| January 14, 2015 | K143412 | ADROIT Guiding Catheter | DQY | Substantially Equivalent | Cordis Corporation | accessdata.fda.gov |
| June 27, 2014 | K133843 | SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER | LIT | Substantially Equivalent | Cordis Corporation | accessdata.fda.gov |
| March 7, 2014 | K140286 | OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER | DTK | Substantially Equivalent | Cordis, A Johnson & Johnson Co. | accessdata.fda.gov |
| May 29, 2013 | K131225 | ADROIT GUIDING CATHETER | DQY | Substantially Equivalent | Cordis Corp., A Johnson & Johnson Co. | accessdata.fda.gov |
| July 6, 2012 | K121125 | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM | FGE | Unknown | Flexible Stenting Solutions, Inc. | accessdata.fda.gov |
| May 4, 2012 | K112797 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | LIT | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| February 4, 2010 | K091077 | OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER | DTK | Substantially Equivalent | Cordis Corp., A Johnson & Johnson Co. | accessdata.fda.gov |
| February 6, 2008 | K062798 | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB | FGE | Unknown | Cordis Corp. | accessdata.fda.gov |
| May 16, 2007 | K071189 | CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Cordis Europa, N.V. | accessdata.fda.gov |
| November 8, 2004 | K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | Cordis Corp. | accessdata.fda.gov |
| June 21, 2004 | K040413 | CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM | FGE | Unknown | Cordis Europa, N.V. | accessdata.fda.gov |
| January 7, 2004 | K033535 | LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES | PDU | Substantially Equivalent | Lumend, Inc. | accessdata.fda.gov |
| December 22, 2003 | K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM | FGE | Unknown | Cordis Corp. | accessdata.fda.gov |
| October 2, 2003 | K032737 | CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA | DQY | Substantially Equivalent | Cordis Europa, N.V. | accessdata.fda.gov |
| July 7, 2003 | K031777 | MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | Cordis Corp. | accessdata.fda.gov |
| December 18, 2002 | K023907 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER | KNQ | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| June 28, 2002 | K021345 | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM | FGE | Unknown | Cordis Corp. | accessdata.fda.gov |
| June 13, 2002 | K021593 | MODIFICATION TO ENVOY AND VISTA BRITE TIP | DQY | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| April 12, 2002 | K020809 | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT | FGE | Unknown | Cordis Corp. | accessdata.fda.gov |
| March 20, 2002 | K020316 | CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU | DQO | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| August 28, 2001 | K011905 | SNIPER ELITE MODEL-OR-E3872XX SERIES | DQX | Substantially Equivalent | Maxxim Medical | accessdata.fda.gov |
| August 27, 2001 | K010411 | PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM | FGE | Unknown | Cordis Corp. | accessdata.fda.gov |
| August 1, 2001 | K012090 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT | FGE | Unknown | Cordis, A Johnson & Johnson Co. | accessdata.fda.gov |
| August 1, 2001 | K012087 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT | FGE | Unknown | Cordis Corp. | accessdata.fda.gov |
| August 1, 2001 | K012056 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM | FGE | Unknown | Cordis Europa, N.V. | accessdata.fda.gov |
| June 6, 2001 | K010083 | TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A | DTK | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| May 3, 2000 | K000579 | TEMPO AQUA ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| April 28, 2000 | K001136 | CORDIS INTRODUCER GUIDE | DQY | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| March 31, 2000 | K000715 | ENVOY AND VISTA BRITE TIP | DQY | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| January 18, 2000 | K993720 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER | KNQ | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| January 13, 2000 | K994358 | ATW MARKER WIRE STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| October 29, 1999 | K993091 | PALMAZ XL TANSHEPATIC BILIARY STENTS | FGE | Unknown | Cordis Corp. | accessdata.fda.gov |
| October 12, 1999 | K992673 | VISTA BRITE TIP CATHETERS | DQY | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| December 23, 1998 | K984500 | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | DYB | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| October 1, 1998 | K983023 | MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | DYB | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| October 21, 1997 | K972978 | VISTA BRITE TIP GUIDING CATHETERS | DQY | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| September 30, 1997 | K970854 | 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| July 23, 1997 | K965247 | ENVOY GUIDING CATHETER | DQY | Substantially Equivalent | Cordis Neurovascular, Inc. | accessdata.fda.gov |
| July 14, 1997 | K971572 | VISTA BRITE TIP CATHETERS | DQY | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| May 7, 1997 | K963962 | VISTA BRITE TIP CATHETERS | DQY | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| April 24, 1997 | K970392 | CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM | DRE | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| February 21, 1997 | K962765 | CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS) | DQX | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| February 20, 1997 | K963000 | MAXI LD PTA BALLOON CATHETER | LIT | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| November 13, 1996 | K963214 | CORDIS ST STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| October 25, 1996 | K962932 | CORDIS STABILIZER PLUS XS | DQX | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| October 11, 1996 | K962746 | CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT | DYB | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| December 28, 1995 | K954595 | CORDIS BRITE TIP SHEATH INTRODUCER | DYB | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| November 7, 1995 | K953760 | CORDIS WIZDOM STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| March 31, 1994 | K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| January 6, 1994 | K933235 | CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF | DWZ | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| February 11, 1992 | K915836 | CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS | DQO | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| December 13, 1991 | K914138 | ONTRAC | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| November 22, 1991 | K914352 | CORDIS OBTURATOR | DYB | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| October 18, 1991 | K914007 | CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH | DQO | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| June 27, 1986 | K862006 | STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH | DQO | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| August 20, 1981 | K812231 | INTRAVENOUS ADMINISTRATION SET | FPA | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| April 17, 1981 | K810849 | CORDIS BIOPSY FORCEPS | DWZ | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 21, 2023 | P220004 | PALMAZ MULLINS XD Pulmonary Stent | QWC | 2 | September 5, 2024 | accessdata.fda.gov |
| November 7, 2012 | P120002 | SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS | NIP | 33 | October 15, 2026 | accessdata.fda.gov |
| May 19, 2011 | P100013 | CORDIS EXOSEAL VASCULAR CLOSURE DEVICE | MGB | 32 | June 23, 2026 | accessdata.fda.gov |
| September 22, 2006 | P030047 | CORDIS PRECISE NITINOL STENT SYSTEM | NIM | 51 | June 5, 2026 | accessdata.fda.gov |
| August 17, 2005 | P040044 | MATRIX VASCULAR CLOSURE SYSTEM (VSG) | MGB | 107 | May 14, 2026 | accessdata.fda.gov |
| August 12, 2003 | P020036 | S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM | NIO | 57 | October 15, 2026 | accessdata.fda.gov |
| September 27, 1991 | P890017 | PALMAZ BALLOON EXPANDABLE STENT | NIN | 18 | December 20, 2022 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 4, 2025 | 96418 | Class II | Ongoing | Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only | product mix-up; Vascular stent labeled as one size but contains a different size. | accessdata.fda.gov |
| February 7, 2025 | 96272 | Class II | Ongoing | Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular | Catheter manufactured at the incorrect length. | accessdata.fda.gov |
| November 28, 2023 | 93617 | Class II | Ongoing | MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites. | Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary labe | accessdata.fda.gov |
| September 26, 2023 | 93174 | Class I | Ongoing | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter | Non-sterile product labeled as sterile was distributed. | accessdata.fda.gov |
| March 24, 2023 | 91922 | Class I | Ongoing | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. | accessdata.fda.gov |
| November 7, 2022 | 91138 | Class II | Ongoing | Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient. | There is a potential for separation at the male connector. | accessdata.fda.gov |
| May 20, 2022 | 90253 | Class II | Ongoing | PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO.035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX. | Potential for stent dislodgement and associated failures related to two specific sizes of the device. | accessdata.fda.gov |
| October 1, 2021 | 88821 | Class II | Ongoing | SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. | There is a potential for distal tip dislodgement or separation. | accessdata.fda.gov |
| July 21, 2021 | 88372 | Class I | Terminated | Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement. | accessdata.fda.gov |
| July 19, 2021 | 88348 | Class II | Terminated | Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X | The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon. | accessdata.fda.gov |
| June 9, 2021 | 88112 | Class II | Terminated | Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. | The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. | accessdata.fda.gov |
| February 11, 2021 | 87329 | Class I | Completed | PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940 | Distal tip may become separated from the lumen wire in specific lots. | accessdata.fda.gov |
| January 8, 2020 | 84680 | Class II | Terminated | Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S | Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area. | accessdata.fda.gov |
| October 4, 2019 | 83977 | Class II | Terminated | Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. | Product was manufactured utilizing an expired inner body. | accessdata.fda.gov |
| February 7, 2019 | 82481 | Class III | Terminated | Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular syst | Frayed pieces of the mounting card being inside the primary packaging. | accessdata.fda.gov |
| September 5, 2018 | 81294 | Class II | Terminated | Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of | Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test). | accessdata.fda.gov |
| November 15, 2017 | 78674 | Class II | Terminated | Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree. | Potential for cracked luer hubs | accessdata.fda.gov |
| February 16, 2017 | 76800 | Class II | Terminated | Cordis S.M.A.R.T. Flex Vascular Stent System | Deployment Difficulty. | accessdata.fda.gov |
| May 4, 2016 | 74097 | Class II | Terminated | Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) | Inability to deploy the stent or partial stent deployment. | accessdata.fda.gov |
| December 31, 2015 | 73183 | Class II | Terminated | CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A ve | Incorrect cannula of the sheath introducer (smaller than intended). | accessdata.fda.gov |
| December 22, 2014 | 70080 | Class II | Terminated | Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic | One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized. | accessdata.fda.gov |
| June 23, 2014 | 68834 | Class II | Terminated | Cordis EMPIRA NC RX PTCA Dilatation Catheter | The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery | accessdata.fda.gov |
| April 15, 2014 | 70741 | Class II | Terminated | RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure. | Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter. | accessdata.fda.gov |
| September 27, 2013 | 66483 | Class II | Terminated | Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when antico | Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter. | accessdata.fda.gov |
| August 12, 2013 | 66026 | Class II | Terminated | Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. | Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension. | accessdata.fda.gov |
| April 23, 2013 | 65182 | Class II | Terminated | FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. | Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch. | accessdata.fda.gov |
| March 29, 2013 | 65482 | Class I | Terminated | Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis*** | Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards. | accessdata.fda.gov |
| February 5, 2013 | 64273 | Class II | Terminated | Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. | Dilatation catheters could exhibit radial versus axial tears should they burst during inflation. | accessdata.fda.gov |
| October 29, 2012 | 63827 | Class II | Terminated | Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who h | Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700. | accessdata.fda.gov |
| April 9, 2012 | 61713 | Not yet classified | Terminated | Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation | Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in the Tyvek packaging. | accessdata.fda.gov |
| January 31, 2012 | 61098 | Not yet classified | Terminated | S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB, CxxyyySB, Cxxyyy | Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches. | accessdata.fda.gov |
| November 21, 2011 | 60392 | Not yet classified | Terminated | SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm.038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot*** | Cordis Corporation is issuing a Correction for their SUPER TORQUE MB Angiographic Catheter after receiving a report of marker bands dislodged during a procedure. Model Numbers 532598A, 532598B, 532598C, 532598D, SRD5724MB and SRD5727MB are affected by the Cordis Correction. | accessdata.fda.gov |
| January 31, 2011 | 62927 | Class II | Terminated | Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation C | On 1/20/2011 Cordis Corporation, Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled. | accessdata.fda.gov |
| January 28, 2010 | 54547 | Not yet classified | Terminated | Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, 15076364. | Sterility compromised: Cordis found a pin hole in one of the packaging tray cavities.On January 28, 2010 Cordis Corporation initiated a recall on their AVANTI + Introducer. During routine inspection, a visual irregularity was detected in packing trays. | accessdata.fda.gov |
| October 15, 2009 | 53574 | Not yet classified | Terminated | Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33 | Cordis has received complaints of stretching or fracture of the sheath shaft during use. | accessdata.fda.gov |
| August 25, 2009 | 53953 | Not yet classified | Terminated | Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter.035" Tip Length Flexible 3 cm, Sterile. Contents 5 Hydrophilic guidewires and torquing devices. | Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number). | accessdata.fda.gov |
| August 20, 2008 | 49392 | Not yet classified | Terminated | Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires within the peripheral vasculature. The cannula is a nitinol nee | The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. The cannula is unable to be retracted into the device after deployment due to a separation of the inner key from the cannula. | accessdata.fda.gov |
| June 30, 2008 | 50154 | Not yet classified | Terminated | MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral V | Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter. | accessdata.fda.gov |
| March 10, 2008 | 47347 | Not yet classified | Terminated | CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in Mexico. Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease. | Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. This condition may result in a separation of the device. If a separation was to occur, and the separated fragment of lumen material was not retrieved o | accessdata.fda.gov |
| January 14, 2008 | 46378 | Not yet classified | Terminated | CORDIS "Dura Star" 2.25 x 10 Dilatation Catheter, Catalog # 70110225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 | Slow Deflation or No Deflation | accessdata.fda.gov |
| July 21, 2006 | 35940 | Not yet classified | Terminated | CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503558. | Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation. | accessdata.fda.gov |
| June 26, 2006 | 35747 | Not yet classified | Terminated | Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T, 534628T, 534629T, 534635T, 534637T, 534 | The tip of the catheter may separate from the body during operation. | accessdata.fda.gov |
| May 11, 2005 | 32576 | Not yet classified | Terminated | Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, The Netherlands***'' | During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is recalling the six affected lots of Powerflex P3. There is no patient impact. | accessdata.fda.gov |
| January 12, 2005 | 30903 | Not yet classified | Terminated | Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents. | Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met. | accessdata.fda.gov |
| December 7, 2004 | 30637 | Not yet classified | Terminated | VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter. | Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process. | accessdata.fda.gov |
| November 18, 2004 | 30826 | Not yet classified | Terminated | Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx | Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004. | accessdata.fda.gov |
| May 5, 2004 | 29574 | Not yet classified | Terminated | Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S | The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters. | accessdata.fda.gov |
| January 13, 2004 | 28840 | Not yet classified | Terminated | This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Johnson Company ENDOVASCU | Air may be introduced into this Stent system when used with certain size acessory devices. | accessdata.fda.gov |
| September 26, 2003 | 27450 | Not yet classified | Terminated | The device is in a tyvek pouch and is labeled in part: Aviator Peripheral Dilatation Catheter REF Cat. No. Lot No., Use By Manufactured for: Cordis Europa N.V. 9301 LJRoden The Netherlands Method of Sterilization ETO Min | A packaging defect may compromise the device's sterility barrier. | accessdata.fda.gov |
| August 29, 2003 | 27138 | Not yet classified | Terminated | CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L | Some devices may have an incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length of 104mm. | accessdata.fda.gov |
| May 5, 2003 | 26333 | Not yet classified | Terminated | Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only). | Reports of broken or separated tips of the catheter sheath introducers. | accessdata.fda.gov |
| February 3, 2003 | 25712 | Not yet classified | Terminated | The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES. and lot numbers. Product is packed in a Tyvek pouch and further packed into a shelf carton. Product Nu | The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances. | accessdata.fda.gov |
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Updated April 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.