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Cordis US Corp.

United States·US-MF-000020031

Last updated September 17, 2026

Information

Country: United States
Address: 14201 , North West 60th Avenue, Miami Lakes, United States
Website: www.cordis.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Miguel Avila
EUDAMED SRN: US-MF-000020031
FDA FEI Number: 1016427
DUNS Number: 118274128

Catalogue (5574)

Page 3 of 112

Device	Model / Reference	Registries	Class	Status
Infiniti	CP0427	FDA UDI	Class II	Active
Emerald	502532	FDA UDI	Class II	Unknown
Vista Brite Tip	77804400	FDA UDI	Class II	Active
Vista Brite Tip	670-034-00M	FDA UDI	Class II	Active
Supertorque	532511	FDA UDI	Class II	Active
Infiniti	SRD5739	FDA UDI	Class II	Active
Smart Flex	SF07030MB	FDA UDI	Class II	Unknown
Palmaz Genesis	PG3910B	FDA UDI	Class II	Active
SABER .014 PTA Dilatation Catheter	47025120S	FDA UDI	Class II	Active
SABERX .014 PTA Dilatation Catheter	47560150M	FDA UDI	Class II	Active
Saber	48007008S	FDA UDI	Class II	Active
Infiniti	SRD7019	FDA UDI	Class II	Active
Infiniti	CP0203	FDA UDI	Class II	Active
Emerald	502704	FDA UDI	Class II	Active
S.m.a.r.t. Radianz	SR07080XL	FDA UDI	Class III	Active
SABERX .014 PTA Dilatation Catheter	47520150L	FDA UDI	Class II	Active
Adroit	67208200	FDA UDI	Class II	Active
Vista Brite Tip	SM7379	FDA UDI	Class II	Active
Super Torque	SRD6868	FDA UDI	Class II	Active
Vista Brite Tip	MODG18551	FDA UDI	Class II	Active
Cordis PRECISE Nitinol Stent System	P05040XC	FDA UDI	Class III	Active
Super Torque	SR3463	FDA UDI	Class II	Active
Vista Brite Tip	SM7580	FDA UDI	Class II	Active
SABER .014 PTA Dilatation Catheter	47025080S	FDA UDI	Class II	Active
Vista Brite Tip	67021255	FDA UDI	Class II	Active
Super Torque	CP0318	FDA UDI	Class II	Active
Super Torque	SR3008	FDA UDI	Class II	Active
Infiniti	CP0088	FDA UDI	Class II	Active
Super Torque	SR4445	FDA UDI	Class II	Active
Infiniti	SRD5216	FDA UDI	Class II	Active
Powerflex	4206080L	FDA UDI	Class II	Active
Super Torque	SR4146	FDA UDI	Class II	Active
Super Torque	MODC18293	FDA UDI	Class II	Active
Infiniti	CP0390	FDA UDI	Class II	Active
Vista Brite Tip	SM6775	FDA UDI	Class II	Active
Savvy	435353L	FDA UDI	Class II	Unknown
Cordis	598942	FDA UDI	Class II	Active
SABER .014 PTA Dilatation Catheter	47040150M	FDA UDI	Class II	Active
Precise	N830SB	FDA UDI	Class III	Unknown
Powerflex	4158060T	FDA UDI	Class II	Active
Stabilizer	507914X	FDA UDI	Class II	Active
Cordis	SR2170	FDA UDI	Class II	Unknown
SABERX .014 PTA Dilatation Catheter	47520300M	FDA UDI	Class II	Active
Vista Brite Tip	77828090	FDA UDI	Class II	Active
Savvy	435206S	FDA UDI	Class II	Unknown
SABERX .014 PTA Dilatation Catheter	47530100M	FDA UDI	Class II	Active
SABER .014 PTA Dilatation Catheter	47035100M	FDA UDI	Class II	Active
Opta	4194040S	FDA UDI	Class II	Active
SABERX .014 PTA Dilatation Catheter	47520020L	FDA UDI	Class II	Active
Infiniti	MODC17574	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Cordis Cashel IE

Importers

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Notified Bodies

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Authorities

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 4, 2025	Z-1510-2025	—	open, classified	product mix-up; Vascular stent labeled as one size but contains a different size.
Mar 4, 2025	Z-1511-2025	—	open, classified	product mix-up; Vascular stent labeled as one size but contains a different size.
Feb 7, 2025	Z-1330-2025	—	open, classified	Catheter manufactured at the incorrect length.
Nov 28, 2023	Z-0675-2024	—	open, classified	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 label on individual devices is correct.
Nov 28, 2023	Z-0674-2024	—	open, classified	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 label on individual devices is correct.
Sep 26, 2023	Z-0286-2024	—	open, classified	Non-sterile product labeled as sterile was distributed.
Mar 24, 2023	Z-1494-2023	—	open, classified	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.
Mar 24, 2023	Z-1495-2023	—	open, classified	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.
Mar 24, 2023	Z-1484-2023	—	open, classified	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.
Mar 24, 2023	Z-1491-2023	—	open, classified	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.
Mar 24, 2023	Z-1486-2023	—	open, classified	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.
Mar 24, 2023	Z-1483-2023	—	open, classified	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.
Mar 24, 2023	Z-1487-2023	—	open, classified	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.
Mar 24, 2023	Z-1489-2023	—	open, classified	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.
Mar 24, 2023	Z-1485-2023	—	open, classified	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.
Mar 24, 2023	Z-1492-2023	—	open, classified	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.
Mar 24, 2023	Z-1488-2023	—	open, classified	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.
Mar 24, 2023	Z-1490-2023	—	open, classified	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.
Mar 24, 2023	Z-1496-2023	—	open, classified	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.
Mar 24, 2023	Z-1493-2023	—	open, classified	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.
Nov 7, 2022	Z-0720-2023	—	open, classified	There is a potential for separation at the male connector.
May 20, 2022	Z-1363-2022	—	open, classified	Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Oct 1, 2021	Z-0217-2022	—	open, classified	There is a potential for distal tip dislodgement or separation.
Oct 1, 2021	Z-0218-2022	—	open, classified	There is a potential for distal tip dislodgement or separation.
Oct 1, 2021	Z-0220-2022	—	open, classified	There is a potential for distal tip dislodgement or separation.
Oct 1, 2021	Z-0221-2022	—	open, classified	There is a potential for distal tip dislodgement or separation.
Oct 1, 2021	Z-0216-2022	—	open, classified	There is a potential for distal tip dislodgement or separation.
Oct 1, 2021	Z-0219-2022	—	open, classified	There is a potential for distal tip dislodgement or separation.
Jul 21, 2021	Z-2428-2021	—	terminated	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.
Jul 21, 2021	Z-2429-2021	—	terminated	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.
Jul 21, 2021	Z-2432-2021	—	terminated	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.
Jul 21, 2021	Z-2430-2021	—	terminated	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.
Jul 21, 2021	Z-2431-2021	—	terminated	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.
Jul 19, 2021	Z-2235-2021	—	terminated	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.
Jun 9, 2021	Z-2079-2021	—	terminated	The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Feb 11, 2021	Z-1257-2021	—	completed	Distal tip may become separated from the lumen wire in specific lots.
Jan 8, 2020	Z-1477-2020	—	terminated	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.
Oct 4, 2019	Z-0250-2020	—	terminated	Product was manufactured utilizing an expired inner body.
Feb 7, 2019	Z-1198-2019	—	terminated	Frayed pieces of the mounting card being inside the primary packaging.
Sep 5, 2018	Z-0390-2019	—	terminated	Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Nov 15, 2017	Z-0324-2018	—	terminated	Potential for cracked luer hubs
Feb 16, 2017	Z-1826-2017	—	terminated	Deployment Difficulty.
May 4, 2016	Z-1946-2016	—	terminated	Inability to deploy the stent or partial stent deployment.
May 4, 2016	Z-1947-2016	—	terminated	Inability to deploy the stent or partial stent deployment.
Dec 31, 2015	Z-1174-2016	—	terminated	Incorrect cannula of the sheath introducer (smaller than intended).
Dec 22, 2014	Z-0998-2015	—	terminated	One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Jun 23, 2014	Z-2556-2014	—	terminated	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.
Jun 23, 2014	Z-2557-2014	—	terminated	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.
Apr 15, 2014	Z-2405-2015	—	terminated	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.
Sep 27, 2013	Z-0081-2014	—	terminated	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.
Aug 12, 2013	Z-0003-2014	—	terminated	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.
Apr 23, 2013	Z-1507-2013	—	terminated	Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Apr 23, 2013	Z-1510-2013	—	terminated	Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Apr 23, 2013	Z-1508-2013	—	terminated	Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Apr 23, 2013	Z-1511-2013	—	terminated	Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Apr 23, 2013	Z-1509-2013	—	terminated	Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Mar 29, 2013	Z-1887-2013	—	terminated	Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Feb 5, 2013	Z-1784-2014	—	terminated	Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Oct 29, 2012	Z-0740-2013	—	terminated	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.
Apr 9, 2012	Z-1508-2012	—	terminated	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.
Apr 9, 2012	Z-1507-2012	—	terminated	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.
Jan 31, 2012	Z-1040-2012	—	terminated	Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Nitinol Iliac Stent System due to a potential sterility breach in the pouches.
Jan 31, 2012	Z-1039-2012	—	terminated	Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches.
Nov 21, 2011	Z-0204-2012	—	terminated	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.
Nov 21, 2011	Z-0205-2012	—	terminated	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.
Jan 31, 2011	Z-2442-2012	—	terminated	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.
Jan 31, 2011	Z-2441-2012	—	terminated	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.
Jan 28, 2010	Z-1421-2010	—	terminated	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.
Oct 15, 2009	Z-0087-2010	—	terminated	Cordis has received complaints of stretching or fracture of the sheath shaft during use.
Aug 25, 2009	Z-0623-2010	—	terminated	Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).
Aug 20, 2008	Z-0279-2009	—	terminated	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.
Jun 30, 2008	Z-0604-2009	—	terminated	Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter.
Mar 10, 2008	Z-1556-2008	—	terminated	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 on the guidewire, blockage of the vessel
Jan 14, 2008	Z-0822-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0766-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0804-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0798-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0754-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0781-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0796-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0771-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0812-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0793-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0820-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0790-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0801-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0815-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0795-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0750-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0759-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0808-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0777-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0773-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0760-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0775-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0791-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0767-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0782-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0785-2008	—	terminated	Slow Deflation or No Deflation
Jan 14, 2008	Z-0778-2008	—	terminated	Slow Deflation or No Deflation