7 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
FDA Recall
Terminated
·Cordis Corporation·Product code NIP·April 23, 2013
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Recall
Terminated
·Cordis Corporation·Product code FGE·April 23, 2013
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
FDA Recall
Terminated
·Cordis Corporation·Product code FGE·April 23, 2013
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
FDA Recall
Terminated
·Cordis Corporation·Product code NIP·April 23, 2013
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
FDA Recall
Terminated
·Cordis Corporation·Product code NIP·April 23, 2013
SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use By***Sterile EO***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN SRD5724MB, No MB 2, Length, cm 100, Sideholes 2. UPN SRD5727MB, No MB 4, Length, cm 80, Sideholes 4. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
FDA Recall
Terminated
·Cordis Corporation·Product code DQO·November 21, 2011
SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN H739532598A3, Cat No 532-598A, No. MB 10, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H73953298C3, Cat No 532-598C, No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30, Side Holes 6. UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape (PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
FDA Recall
Terminated
·Cordis Corporation·Product code DQO·November 21, 2011