FDA announces recall of 25,000 catheters after 167 complaints, 8 injuries
The FDA has announced that Cordis Corporation is recalling its Super Torque MB Angiographic Catheter, used to visualize and evaluate the patient’s vascular system, due to issues with the device’s radiopaque marker bands moving or coming loose during procedures.
“This can happen during procedures where the catheter is trapped between another device and the vessel wall,” according to the FDA. “If this happens this could cause serious adverse events including delays in the procedure, the need for added medical procedures, heart attack or stroke.”
This is a Class I recall, meaning the use of this device “may cause serious injuries or death.” There have been 167 complaints so far, including eight injuries. No deaths have been reported at this time.
The recall includes 25,000 units distributed from January 2019 to July 2021. Cordis is asking customers to “maintain awareness of this communication” until the device’s labeling can be updated to reflect the risk.
Click here for the full FDA advisory.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.