Medical DeviceNov 24, 2021
Cordis SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated recall — FDA Z-0218-2022
There is a potential for distal tip dislodgement or separation.
Class IIFDA: OngoingCordis Corporation
Recall history in this database
Classification mix: Class II: 18, Class I: 7, Class III: 1.
Medical DeviceNov 24, 2021
Cordis SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated recall — FDA Z-0220-2022
There is a potential for distal tip dislodgement or separation.
Class IIFDA: OngoingCordis Corporation
Medical DeviceNov 24, 2021
Cordis SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated recall — FDA Z-0221-2022
There is a potential for distal tip dislodgement or separation.
Class IIFDA: OngoingCordis Corporation
Medical DeviceNov 24, 2021
Cordis SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for recall — FDA Z-0219-2022
There is a potential for distal tip dislodgement or separation.
Class IIFDA: OngoingCordis Corporation
Medical DeviceNov 24, 2021
Cordis SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for recall — FDA Z-0216-2022
There is a potential for distal tip dislodgement or separation.
Class IIFDA: OngoingCordis Corporation
Medical DeviceNov 24, 2021
Cordis SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated recall — FDA Z-0217-2022
There is a potential for distal tip dislodgement or separation.
Class IIFDA: OngoingCordis Corporation
Medical DeviceSep 22, 2021
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB recall — FDA Z-2428-2021
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…
Class IFDA: TerminatedCordis Corporation
Medical DeviceSep 22, 2021
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C recall — FDA Z-2432-2021
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…
Class IFDA: TerminatedCordis Corporation
Medical DeviceSep 22, 2021
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B recall — FDA Z-2431-2021
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…
Class IFDA: TerminatedCordis Corporation
Medical DeviceSep 22, 2021
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB recall — FDA Z-2429-2021
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…
Class IFDA: TerminatedCordis Corporation
Medical DeviceSep 22, 2021
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A recall — FDA Z-2430-2021
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…
Class IFDA: TerminatedCordis Corporation
Medical DeviceAug 18, 2021
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X recall — FDA Z-2235-2021
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…
Class IIFDA: TerminatedCordis Corporation
Medical DeviceJul 21, 2021
Cordis Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial recall — FDA Z-2079-2021
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Class IIFDA: TerminatedCordis Corporation
Medical DeviceMar 24, 2021
Cordis PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC recall — FDA Z-1257-2021
Distal tip may become separated from the lumen wire in specific lots.
Class IFDA: CompletedCordis Corporation
Medical DeviceApr 24, 2019
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is recall — FDA Z-1198-2019
Frayed pieces of the mounting card being inside the primary packaging.
Class IIIFDA: TerminatedCordis Corporation
Medical DeviceNov 14, 2018
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses recall — FDA Z-0390-2019
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Class IIFDA: TerminatedCordis Corporation
Medical DeviceJan 17, 2018
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the recall — FDA Z-0324-2018
Potential for cracked luer hubs
Class IIFDA: TerminatedCordis Corporation
Medical DeviceMar 23, 2016
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath recall — FDA Z-1174-2016
Incorrect cannula of the sheath introducer (smaller than intended).
Class IIFDA: TerminatedCordis Corporation
Medical DeviceAug 26, 2015
Cordis RenLane Renal Denervation Catheter recall — FDA Z-2405-2015
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…
Class IIFDA: TerminatedCordis Corporation
Medical DeviceJan 28, 2015
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral recall — FDA Z-0998-2015
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Class IIFDA: TerminatedCordis Corporation
Medical DeviceSep 3, 2014
Cordis EMPIRA NC RX PTCA Dilatation Catheter recall — FDA Z-2556-2014
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…
Class IIFDA: TerminatedCordis Corporation
Medical DeviceSep 3, 2014
Cordis EMPIRA RX PTCA Dilatation Catheter recall — FDA Z-2557-2014
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…
Class IIFDA: TerminatedCordis Corporation
Medical DeviceJun 18, 2014
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use recall — FDA Z-1784-2014
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Class IIFDA: TerminatedCordis Corporation
Medical DeviceNov 6, 2013
Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent recall — FDA Z-0081-2014
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…
Class IIFDA: TerminatedCordis Corporation
Understanding this recall history
This page summarizes recall records in which the official source identifies Cordis Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.