FDA labels Cordis’ recall of angiographic catheters as class I
The FDA has identified Cordis’ recall of its angiographic catheter with radiopaque marker bands as Class I, the most serious type of recall.
According to a press release from the FDA, the recall is due to risk for the catheter marker bands moving or dislodging during procedures, which can result in delayed procedure, additional procedures, MI or stroke.
According to the release, the catheter (Super Torque MB, Cordis) is used to visualize and measure parts of the vascular system when used with radiopaque contrast media.
Movement or dislodging of the radiopaque marker bands can occur when the catheter is trapped between another device and the vessel wall, the FDA stated in the release.
A total of 25,000 units distributed between Jan. 1, 2019, and July 20, 2021 are included in the recall.
According to the release, there have been 167 complaints, 8 injuries and no deaths reported for this issue.