FDA Issues Update on Cordis Catheter Recall

September 24, 2021

The FDA released on update on Cordis’s May 19 recall of its Super Torque MB angiographic catheter with radiopaque marker bands, deeming it a Class 1 recall because of the risk of serious injury or death.

The agency noted that the device’s marker bands may move or dislodge during surgical procedures, which can happen when the catheter is trapped between another device and a vessel wall. This can cause “serious adverse events including delays in the procedure, the need for added medical procedures, heart attack, or stroke,” the FDA said.

The 25,000 affected products were distributed from Jan. 1, 2019 to July 20. The agency said there have been 167 complaints and eight injuries, but no reported deaths linked to the catheters.  

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