Reported Mar 10, 2021 · Terminated
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST…
Acist Medical Systems
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acist Medical Systems · 7905 Fuller Rd · Eden Prairie, MN · 55344-2137
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number
017788018125 (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)
- Model Number
- Amount recalled
- 1185 units
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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