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: 6, Class I: 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
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.