Cordis Corporation
FDA Regulatory Profile
Cordis Corporation appears in FDA public data with 39 recalls — including 7 Class I (most serious) —, 13 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0218-2022, Class II) was initiated on October 1, 2021. Its most recent 510(k) clearance was granted on April 6, 2022.
Summary
- Total Recalls
- 39 (7 Class I)
- 510(k) Clearances
- 13
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0218-2022 | Class II | SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the p | October 1, 2021 |
| Z-0219-2022 | Class II | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the pal | October 1, 2021 |
| Z-0220-2022 | Class II | SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the p | October 1, 2021 |
| Z-0217-2022 | Class II | SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the p | October 1, 2021 |
| Z-0221-2022 | Class II | SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the | October 1, 2021 |
| Z-0216-2022 | Class II | SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the pal | October 1, 2021 |
| Z-2429-2021 | Class I | Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB | July 21, 2021 |
| Z-2430-2021 | Class I | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A | July 21, 2021 |
| Z-2428-2021 | Class I | Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB | July 21, 2021 |
| Z-2432-2021 | Class I | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C | July 21, 2021 |
| Z-2431-2021 | Class I | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B | July 21, 2021 |
| Z-2235-2021 | Class II | Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X | July 19, 2021 |
| Z-2079-2021 | Class II | Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous pro | June 9, 2021 |
| Z-1257-2021 | Class I | PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620 | February 11, 2021 |
| Z-1477-2020 | Class II | Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S | January 8, 2020 |
| Z-0250-2020 | Class II | Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. | October 4, 2019 |
| Z-1198-2019 | Class III | Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intend | February 7, 2019 |
| Z-0390-2019 | Class II | Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in ilia | September 5, 2018 |
| Z-0324-2018 | Class II | Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliatio | November 15, 2017 |
| Z-1826-2017 | Class II | Cordis S.M.A.R.T. Flex Vascular Stent System | February 16, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | April 6, 2022 |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | February 17, 2022 |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | April 23, 2021 |
| K202167 | Brite Tip Radianz Guiding Sheath | February 26, 2021 |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter | October 9, 2020 |
| K201333 | SABER .035 PTA Dilatation Catheter | September 11, 2020 |
| K181592 | RAIN Sheath Transradial | August 15, 2018 |
| K180081 | RAILWAY Sheathless Access System | April 18, 2018 |
| K143412 | ADROIT Guiding Catheter | January 14, 2015 |
| K133843 | SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER | June 27, 2014 |
| K121442 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | June 14, 2012 |
| K041796 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | August 3, 2004 |
| K034050 | CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C22 | March 22, 2004 |