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Cordis Corporation FDA Recalls

14 recalls on file across devices, 6 of them Class I and 6 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignClass IIOct 1, 2021There is a potential for distal tip dislodgement or separati	There is a potential for distal tip dislodgement or separation.	Class IIDevices	Oct 1, 2021
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignantClass IIOct 1, 2021There is a potential for distal tip dislodgement or separati	There is a potential for distal tip dislodgement or separation.	Class IIDevices	Oct 1, 2021
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignaClass IIOct 1, 2021There is a potential for distal tip dislodgement or separati	There is a potential for distal tip dislodgement or separation.	Class IIDevices	Oct 1, 2021
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignaClass IIOct 1, 2021There is a potential for distal tip dislodgement or separati	There is a potential for distal tip dislodgement or separation.	Class IIDevices	Oct 1, 2021
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignantClass IIOct 1, 2021There is a potential for distal tip dislodgement or separati	There is a potential for distal tip dislodgement or separation.	Class IIDevices	Oct 1, 2021
SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignaClass IIOct 1, 2021There is a potential for distal tip dislodgement or separati	There is a potential for distal tip dislodgement or separation.	Class IIDevices	Oct 1, 2021
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598CClass IJul 21, 2021Cordis has identified that the SUPER TORQUE MB Angiographic	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a m	Class IDevices	Jul 21, 2021
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MBClass IJul 21, 2021Cordis has identified that the SUPER TORQUE MB Angiographic	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a m	Class IDevices	Jul 21, 2021
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598AClass IJul 21, 2021Cordis has identified that the SUPER TORQUE MB Angiographic	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a m	Class IDevices	Jul 21, 2021
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MBClass IJul 21, 2021Cordis has identified that the SUPER TORQUE MB Angiographic	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a m	Class IDevices	Jul 21, 2021
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598BClass IJul 21, 2021Cordis has identified that the SUPER TORQUE MB Angiographic	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a m	Class IDevices	Jul 21, 2021
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010XClass IIJul 19, 2021The balloon protective sheath may potentially be contaminate	The balloon protective sheath may potentially be contaminated with a foreign material left over from the manuf	Class IIDevices	Jul 19, 2021
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring peClass IIJun 9, 2021The product in the packaging is larger (both inner and outer	The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.	Class IIDevices	Jun 9, 2021
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC06Class IFeb 11, 2021Distal tip may become separated from the lumen wire in speci	Distal tip may become separated from the lumen wire in specific lots.	Class IDevices	Feb 11, 2021

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