ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter i...

FDA Device Recall #Z-1161-2021 — Class I — January 22, 2021

Recall Summary

Recall Number Z-1161-2021
Classification Class I — Serious risk
Date Initiated January 22, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Acist Medical Systems
Location Eden Prairie, MN
Product Type Devices
Quantity 1185 units

Product Description

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.

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.

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.

Lot / Code Information

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)

Other Recalls from Acist Medical Systems

Recall # Classification Product Date
Z-0744-2016 Class II ACIST Medical Systems, BT2000 Automated Manifol... Dec 21, 2015
Z-1145-2013 Class II ACIST Medical Systems Inc. The ACIST Angiogr... Mar 15, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.