The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- ACIST Kodama Intravascular Ultrasound Catheter
- Lots: 00233370, 00233371, 00233372, 00233373, 00233385
- Distribution Dates: November 10, 2020 to January 14, 2021
- Devices Recalled in the U.S.: 490
- Date Initiated by Firm: January 18, 2021
The ACIST Kodama Intravascular Ultrasound Catheter (HD-IVUS) uses high-frequency sound waves (ultrasound), to view the inside of an artery, including the structure of the artery, and any devices such as stents. It is inserted through an artery in the leg and guided to the area that health care providers need to see.
This catheter is intended to be used with the ACIST HDi System.
Reason for Recall
ACIST Medical Systems is recalling their ACIST Kodama Intravascular Ultrasound Catheter because the O-ring housing tubing may squeeze and damage the O-ring (see Fig. 1). If there is damage, pieces of the O-ring may break free and flush into the patient’s artery during use. This could cause serious patient harm including vessel blockage, heart attack, heart arrhythmia, or stroke, with associated chest pain or discomfort. Patients with heart ventricles that do not function properly are at higher risk of experiencing serious harm due to sudden blockage of blood flow. Additionally, if the HD-IVUS catheter is imaging an artery that supplies blood to another partly blocked or narrowed artery, there is a higher risk of blockages in more than one artery.
There have been no complaints, injuries, or deaths reported.
Who May be Affected
- Health care providers using the affected Kodama HD-IVUS catheter
- Patients who require care using the affected Kodama HD-IVUS Catheter
What to Do
On January 22, 2021, ACIST sent an Urgent Medical Device Recall letter to all affected customers. The letter gave the following instructions:
- Check inventory of Kodama HD-IVUS Catheter for the following Lot Numbers: 00233370, 00233371, 00233372, 00233373, 00233385.
- Record quantities of each lot in the Response Form included with the recall notice letter.
- Remove the affected lots from inventory.
- Use prepaid return label enclosed with the recall notice letter to return affected product along with a completed Recall Response Form to Stericycle by e-mail: email@example.com or fax to 877-576-9366.
- Additional labels can be obtained by contacting Stericycle at 877-576-9382.
Any reports of illness, injury or other health consequence related to the use of the lot codes listed should be reported to Customer Support: Customer.Support@acistmedical.com
For questions or concerns, please contact Stericycle by phone at 877-576-9382 from 8 a.m. to 5 p.m. EST, Monday to Friday.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.