EPA (Environmental Protection Agency)
2 records
fda
31 records
FDA Recall: Cordis Corporation — Class II
20211124
There is a potential for distal tip dislodgement or separation. | Product: SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the p
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FDA Device Recall: SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica
2021-11-24
Class II — There is a potential for distal tip dislodgement or separation.
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FDA Device Recall: SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica
2021-11-24
Class II — There is a potential for distal tip dislodgement or separation.
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FDA Device Recall: SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic
2021-11-24
Class II — There is a potential for distal tip dislodgement or separation.
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FDA Device Recall: SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicate
2021-11-24
Class II — There is a potential for distal tip dislodgement or separation.
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FDA Device Recall: SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicate
2021-11-24
Class II — There is a potential for distal tip dislodgement or separation.
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FDA Device Recall: Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, RE
2021-09-22
Class I — 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...
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FDA Device Recall: Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
2021-09-22
Class I — 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...
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FDA Device Recall: Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
2021-09-22
Class I — 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...
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FDA Device Recall: Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
2021-09-22
Class I — 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...
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FDA Device Recall: Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in art
2021-07-21
Class II — The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
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FDA Recall: Cordis Corporation — Class III
20190424
Frayed pieces of the mounting card being inside the primary packaging. | Product: Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intend
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FDA Device Recall: Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guidin
2019-04-24
Class III — Frayed pieces of the mounting card being inside the primary packaging.
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FDA Recall: Cordis Corporation — Class II
20181114
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test). | Product: Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usag...
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FDA Device Recall: Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dil
2018-11-14
Class II — Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
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FDA Device Recall: Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for
2018-01-17
Class II — Potential for cracked luer hubs
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FDA Device Recall: Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
2016-06-22
Class II — Inability to deploy the stent or partial stent deployment.
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FDA Device Recall: CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Cath
2016-03-23
Class II — Incorrect cannula of the sheath introducer (smaller than intended).
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FDA Device Recall: RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (
2015-08-26
Class II — 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 withdraw...
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FDA Device Recall: Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in i
2015-01-28
Class II — One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
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FDA Device Recall: Cordis EMPIRA NC RX PTCA Dilatation Catheter
2014-09-03
Class II — 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 applie...
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FDA Device Recall: Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascula
2014-06-18
Class II — Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
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FDA Recall: Cordis Corporation — Class II
20131106
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 | Product: Cordis OPTEASE Vena Cava Filter Is ...
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FDA Device Recall: Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of rec
2013-11-06
Class II — 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 re...
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FDA Device Recall: FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXS
2013-06-12
Class II — Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
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FDA Device Recall: FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The F
2013-06-12
Class II — Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
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FDA Device Recall: FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The F
2013-06-12
Class II — Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
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FDA Device Recall: FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The F
2013-06-12
Class II — Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
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FDA Device Recall: FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXS
2013-06-12
Class II — Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
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FDA Device Recall: Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device,
2013-02-06
Class II — Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. ...
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FDA Device Recall: Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon
2012-10-03
Class II — On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is...
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ny_corps
1 records
NY Corp: CORDIS GROUP, LLC
2003-12-10
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: Delaware
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