Cordis Corporation is recalling the Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands due to the potential for the marker bands to move or dislodge during procedures. This can happen during procedures where the catheter is trapped between another device and the vessel wall. If this happens this could cause serious adverse events including delays in the procedure, the need for added medical procedures, heart attack, or stroke.
There have been 167 complaints, 8 injuries, and no deaths reported for this issue. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product:
- Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands
- Distribution Dates: January 1, 2019 to July 20, 2021
- Devices Recalled in the U.S.: 25,000 units
- Date Initiated by Firm: May 19, 2021
The Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands is a catheter used to visualize and measure parts of the vascular system when used with radiopaque (X-ray detectable) contrast media.
