Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Cordis
39 recalls • • Categories: Implants & Prosthetics, Surgical Instruments, Diagnostic Equipment, Infusion Pumps
Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Class I - Dangerous
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 the vessel wall, which can lead to marker band movement or dislodgement.
Class I - Dangerous
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 the vessel wall, which can lead to marker band movement or dislodgement.
Class I - Dangerous
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 the vessel wall, which can lead to marker band movement or dislodgement.
Class I - Dangerous
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 the vessel wall, which can lead to marker band movement or dislodgement.
Class I - Dangerous
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 the vessel wall, which can lead to marker band movement or dislodgement.
Class I - Dangerous
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 balloon.
Class I - Dangerous
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Distal tip may become separated from the lumen wire in specific lots.
Class I - Dangerous
Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
Class I - Dangerous
Product was manufactured utilizing an expired inner body.
Frayed pieces of the mounting card being inside the primary packaging.
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Class I - Dangerous
Potential for cracked luer hubs
Class I - Dangerous
Deployment Difficulty.
Class I - Dangerous
Inability to deploy the stent or partial stent deployment.
Class I - Dangerous
Inability to deploy the stent or partial stent deployment.
Incorrect cannula of the sheath introducer (smaller than intended).
Class I - Dangerous
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 withdrawal of the catheter.
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Class I - Dangerous
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 applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
Class I - Dangerous
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 applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
Class I - Dangerous
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
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 resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter.
Class I - Dangerous
Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Holes and/or tears can be introduced in the FLEXSTENTÂż inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Holes and/or tears can be introduced in the FLEXSTENTÂż inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Holes and/or tears can be introduced in the FLEXSTENTÂż inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Holes and/or tears can be introduced in the FLEXSTENTÂż inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Holes and/or tears can be introduced in the FLEXSTENTÂż inner pouch under some conditions, and to a lesser degree, in the outer pouch.
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. Model Numbers EX500, EX600, and EX700.
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 incorrectly labeled.
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 incorrectly labeled.