Z-1161-2021Class I

ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of...

Name: Z-1161-2021 ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of...
Creator: Acist Medical Systems
Published: 2021-01-22
License: https://open.fda.gov/license/

Acist Medical Systems, Inc. / initiated 2021-01-22 / Terminated / root cause: design

FDA source

Acist Medical Systems began a recall of ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is... on 2021-01-22. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1161-2021
Classification: Class I
Status: Terminated
Initiated: 2021-01-22
Posted: 2021-03-04
Terminated: 2023-10-30
Recalling firm: Acist Medical Systems, Inc.
Product: 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.
Product code: OBJ Catheter, Ultrasound, Intravascular
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 1185 units
Distribution: 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.
Product codes and lots: Model Number: 017788, 018125 (Japan only); Lot codes: 00233370 (100 units), 00233371 (90 units), 00233372 (100 units), 00233373 (100 units), 00233374 (100 units), 00233380 (100 units), 00233384 (60 units), 00233385 (100 units), 00233393 (100 units), 00233394 (100 units), 00237604 (35 units), 00237613 (100 units), 03012517 (100 units)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1161-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1161-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-10	2021-03-04

Product code OBJ

K193183Class IIACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. / cleared 2020-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)