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.
FDA Recall Z-1161-2021 · Posted 2021-03-04
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Recalling FirmAcist Medical Systems
Recall StatusTerminated
Product CodeOBJ
Date Initiated2021-01-22
Date Terminated2023-10-30
Product Quantity1185 units
Reason for Recall
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.
Firm Action
The firm, ACIST, sent an, "URGENT: MEDICAL DEVICE RECALL" letter and response form dated Jan 22, 2021 to customers on Jan. 22, 2021. The letter describe the product, problem and actions to be taken. The customers were instructed to do the following: to complete all of the steps outlined below and return the completed Recall Response Form to Stericycle by e-mail: [email protected] or fax to 877-576-9366.
1. Check your inventory of Kodama HD-IVUS Catheter
2. Record quantities of each lot in the Response Form
3. Remove the affected lots from your inventory.
4. Use the enclosed, prepaid return label to return your affected product including a copy of the response form with the product. If you need additional labels, please contact Stericycle at 877-576-9382.
If you have received any reports of illness, injury or other health consequence related to the use of product please contact Customer Support: [email protected]
Please forward this notice to those who need to be aware within your organization.
If you have any further questions or concerns, please contact
Stericycle at 877-576-9382.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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