Acist Medical Systems recalls ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST…

Recall date

January 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1161-2021

FDA classification

Class I

Brand / firm

Acist Medical Systems

Sold / distributed

Worldwide - US Nationwide Distribution in the states of AL, AR, CA, CO, FL, IL, KS, KY, LA, MD, MI, MO, NC, NJ, NY, OK, PA, RI, TN; In the countries of India, Italy, Japan, Poland, and United Arab Emirates.

Why it was recalled

Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.