Cordis Recalls
39 recalls on record · October 3, 2012 to November 24, 2021 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 24, 2021Medical DevicesFDA
Cordis Corporation recalls SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malign
Hazard: There is a potential for distal tip dislodgement or separation.
November 24, 2021Medical DevicesFDA
Cordis Corporation recalls SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna
Hazard: There is a potential for distal tip dislodgement or separation.
November 24, 2021Medical DevicesFDA
Cordis Corporation recalls SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant
Hazard: There is a potential for distal tip dislodgement or separation.
November 24, 2021Medical DevicesFDA
Cordis Corporation recalls SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna
Hazard: There is a potential for distal tip dislodgement or separation.
November 24, 2021Medical DevicesFDA
Cordis Corporation recalls SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna
Hazard: There is a potential for distal tip dislodgement or separation.
November 24, 2021Medical DevicesFDA
Cordis Corporation recalls SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant
Hazard: There is a potential for distal tip dislodgement or separation.
September 22, 2021Medical DevicesFDA
Cordis Corporation recalls Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
Hazard: 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.
September 22, 2021Medical DevicesFDA
Cordis Corporation recalls Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Hazard: 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.
September 22, 2021Medical DevicesFDA
Cordis Corporation recalls Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
Hazard: 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.
September 22, 2021Medical DevicesFDA
Cordis Corporation recalls Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Hazard: 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.
September 22, 2021Medical DevicesFDA
Cordis Corporation recalls Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Hazard: 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.
August 18, 2021Medical DevicesFDA
Cordis Corporation recalls Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Hazard: 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.
July 21, 2021Medical DevicesFDA
Cordis Corporation recalls Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring pe
Hazard: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
March 24, 2021Medical DevicesFDA
Cordis Corporation recalls PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC06
Hazard: Distal tip may become separated from the lumen wire in specific lots.
March 18, 2020Medical DevicesFDA
Cordis Corporation recalls Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Hazard: 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.
November 6, 2019Medical DevicesFDA
Cordis Corporation recalls Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Hazard: Product was manufactured utilizing an expired inner body.
April 24, 2019Medical DevicesFDA
Cordis Corporation recalls Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intra
Hazard: Frayed pieces of the mounting card being inside the primary packaging.
November 14, 2018Medical DevicesFDA
Cordis Corporation recalls Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-fem
Hazard: Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
January 17, 2018Medical DevicesFDA
Cordis Corporation recalls Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant stric
Hazard: Potential for cracked luer hubs
April 26, 2017Medical DevicesFDA
Cordis Corporation recalls Cordis S.M.A.R.T. Flex Vascular Stent System
Hazard: Deployment Difficulty.
June 22, 2016Medical DevicesFDA
Cordis Corporation recalls Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Hazard: Inability to deploy the stent or partial stent deployment.
June 22, 2016Medical DevicesFDA
Cordis Corporation recalls Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
Hazard: Inability to deploy the stent or partial stent deployment.
March 23, 2016Medical DevicesFDA
Cordis Corporation recalls CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vesse
Hazard: Incorrect cannula of the sheath introducer (smaller than intended).
August 26, 2015Medical DevicesFDA
Cordis Corporation recalls RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertens
Hazard: 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.
January 28, 2015Medical DevicesFDA
Cordis Corporation recalls Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal,
Hazard: One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
September 3, 2014Medical DevicesFDA
Cordis Corporation recalls Cordis EMPIRA RX PTCA Dilatation Catheter
Hazard: 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.
September 3, 2014Medical DevicesFDA
Cordis Corporation recalls Cordis EMPIRA NC RX PTCA Dilatation Catheter
Hazard: 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.
June 18, 2014Medical DevicesFDA
Cordis Corporation recalls Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Hazard: Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
November 6, 2013Medical DevicesFDA
Cordis Corporation recalls Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percu
Hazard: 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.
October 9, 2013Medical DevicesFDA
Cordis Corporation recalls Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic
Hazard: 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.