Cordis Corporation
Complete recall history across all FDA and CPSC categories — 39 total recalls
Cordis Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (39)
FDA medical device enforcement actions by Cordis Corporation
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 1, 2021 | SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... | There is a potential for distal tip dislodgement or separation. | Class II |
| Oct 1, 2021 | SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic... | There is a potential for distal tip dislodgement or separation. | Class II |
| Oct 1, 2021 | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic... | There is a potential for distal tip dislodgement or separation. | Class II |
| Oct 1, 2021 | SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is in... | There is a potential for distal tip dislodgement or separation. | Class II |
| Oct 1, 2021 | SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... | There is a potential for distal tip dislodgement or separation. | Class II |
| Oct 1, 2021 | SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... | There is a potential for distal tip dislodgement or separation. | Class II |
| Jul 21, 2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Ma... | Class I |
| Jul 21, 2021 | Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Ma... | Class I |
| Jul 21, 2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Ma... | Class I |
| Jul 21, 2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Ma... | Class I |
| Jul 21, 2021 | Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter,... | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Ma... | Class I |
| Jul 19, 2021 | Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X | The balloon protective sheath may potentially be contaminated with a foreign ... | Class II |
| Jun 9, 2021 | Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in ... | The product in the packaging is larger (both inner and outer diameter) than t... | Class II |
| Feb 11, 2021 | PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC053... | Distal tip may become separated from the lumen wire in specific lots. | Class I |
| Jan 8, 2020 | Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S | Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due t... | Class II |
| Oct 4, 2019 | Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. | Product was manufactured utilizing an expired inner body. | Class II |
| Feb 7, 2019 | Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The gui... | Frayed pieces of the mounting card being inside the primary packaging. | Class III |
| Sep 5, 2018 | Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to ... | Product may not meet the internal manufacturing shaft subassembly burst stren... | Class II |
| Nov 15, 2017 | Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated f... | Potential for cracked luer hubs | Class II |
| Feb 16, 2017 | Cordis S.M.A.R.T. Flex Vascular Stent System | Deployment Difficulty. | Class II |
| May 4, 2016 | Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) | Inability to deploy the stent or partial stent deployment. | Class II |
| May 4, 2016 | Cordis PRECISE (R) RX Nitinol Stent System (Biliary) | Inability to deploy the stent or partial stent deployment. | Class II |
| Dec 31, 2015 | CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a C... | Incorrect cannula of the sheath introducer (smaller than intended). | Class II |
| Dec 22, 2014 | Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses i... | One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at... | Class II |
| Jun 23, 2014 | Cordis EMPIRA RX PTCA Dilatation Catheter | The balloon may exhibit resistance to the removal of the balloon cover. Weake... | Class II |
| Jun 23, 2014 | Cordis EMPIRA NC RX PTCA Dilatation Catheter | The balloon may exhibit resistance to the removal of the balloon cover. Weake... | Class II |
| Apr 15, 2014 | RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patient... | Potential Damage may occur to the helical tip of the RENLANE Renal Denervatio... | Class II |
| Sep 27, 2013 | Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of ... | Cordis identified a printing error on one unit of the Optease Vena Cava Filte... | Class II |
| Aug 12, 2013 | Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introd... | Due to a labeling error related to the conversion of the inner diameter of th... | Class II |
| Apr 23, 2013 | FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FL... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some... | Class II |
| Apr 23, 2013 | FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some... | Class II |
| Apr 23, 2013 | FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some... | Class II |
| Apr 23, 2013 | FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some... | Class II |
| Apr 23, 2013 | FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FL... | Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some... | Class II |
| Mar 29, 2013 | Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466... | Correction to provide clarification and additional labeling to minimize likel... | Class I |
| Feb 5, 2013 | Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovasc... | Dilatation catheters could exhibit radial versus axial tears should they burs... | Class II |
| Oct 29, 2012 | Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Devi... | Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process... | Class II |
| Jan 31, 2011 | Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon... | On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their... | Class II |
| Jan 31, 2011 | Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Ballo... | On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of thei... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
Explore More Recalls
Search recalls by category, state, reason, or firm across all our databases.