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.

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