ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST
FDA device recall Z-1161-2021 · posted 2021-03-04 · Terminated
Recall details
- Recalling firm
- Acist Medical Systems
- 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.
- Action taken
- 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: acistmedical8961@stericycle.com 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: Customer.Support@acistmedical.com 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
- Status
- Terminated
- Product code
- OBJ
- Quantity affected
- 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 Emi
- Date initiated
- 2021-01-22
- Date posted
- 2021-03-04
- Date terminated
- 2023-10-30
- Location
- Eden Prairie, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (K193183) | Acist Medical Systems, Inc. | 2020-03-20 |