The FDA yesterday designated an Acist Medical Systems recall of Kodama intravascular ultrasound catheters as Class I, its most serious level.
The Kodama intravascular ultrasound catheter (HD-IVUS) is designed to view the inside structure of an artery and any devices therein using high-frequency sound waves. The device is inserted through an artery in the leg and guided to the area that requires imaging.
Acist is recalling the catheter because the O-ring housing tubing may squeeze and damage the O-ring. Pieces of the O-ring may break free and flush into a patient’s artery during use if damaged, which could result in serious patient harm including vessel blockage, heart attack, heart arrhythmia or stroke with associated chest pain or discomfort. There have been no reported complaints, injuries or deaths, according to the FDA warning letter.
Overall, there are 490 devices involved in the recall.
Lot numbers affected in the recall include 00233370, 00233371, 00233372, 00233373 and 00233385 with distribution dates of Nov. 10, 2020 to Jan. 14, 2021.
Acist recommends healthcare providers remove the affected lots from inventory and return them to Stericycle.