Class I Recall for Cordis’ Super Torque Catheters with Radiopaque Markers

Cordis is recalling the Super Torque MB angiographic catheter with radiopaque marker bands, the US Food and Drug Administration announced this week, categorizing the action as a class I recall, the most serious type.

The reason for the recall, the FDA explains, is that the radiopaque marker bands might move or dislodge during procedures. “This can happen during procedures where the catheter is trapped between another device and the vessel wall,” according to the agency. “If this happens, this could cause serious adverse events, including delays in the procedure, the need for added medical procedures, heart attack, or stroke.”

To date, there have been 167 complaints, 8 injuries, and no patient deaths.

Cordis initiated the recall in May 2021 and sent an urgent field safety notice to physicians and hospitals in July. In the letter, the company warned operators not to use the catheter in cases where it might become trapped between endovascular devices and the vessel wall, such as endovascular aneurysm repair/covered stent procedures. In such instances, the catheter might stretch and elongate enough for the marker bands to shift or come off during the procedure.

The class I recall affects 25,000 devices in the US, including the Super Torque MB 5F Pig (REF 532-598B, 532-598A, and 532-598C), 5F Super Torque Pig Pigtail Special (REF SRD7040MB), and 5F Universal Flush F4 Super Torque MB Special (REF SRD6785MB) angiographic catheters. The recall does not affect Super Torque angiographic catheters without marker bands.