Potential Injuries May Include
ACIST Medical Systems recalled 490 ACIST Kodama Intravascular Ultrasound Catheters over concerns that while the device was in use, an O-ring housing tubing could squeeze and damage the O-ring, causing pieces of the device to break free and flush into the patient’s artery. No complaints, injuries, or deaths have thus far been reported, however, if the anticipated damage were to occur, while the ACIST catheter was in use and fine pieces of the unit’s O-ring were to break free and enter the arteries, the following extreme adverse events could occur:
- Blood vessel blockage
- Heart attack
- Heart arrhythmia
- Stroke
- Chest pain or discomfort
