The FDA has listed Cordis as a Class I recall of its angiography catheters with radiopaque marker tape, which is the most serious type of recall.
According to the FDA's press release, the recall is due to the risk of the catheter marker tape moving or falling off during the operation, which may cause delays in the operation, additional operations, myocardial infarction or stroke.
According to the published news, catheters (Super Torque MB, Cordis) are used to visualize and measure various parts of the vascular system when used with radiopaque contrast agents.
The FDA stated in a press release that when the catheter is sandwiched between another device and the vessel wall, movement or displacement of the radiopaque marker may occur.
The recall includes a total of 25,000 units distributed between January 1, 2019 and July 20, 2021.
According to the information released, there have been 167 complaints, 8 people have been injured, and no deaths have been reported.
Send the latest news and education to your inbox
© 2021 Healio All rights reserved.
Send the latest news and education to your inbox
© 2021 Healio All rights reserved.