ACIST Kodama Intravascular Ultrasound Catheter Recalled for Damaged O-Ring
Acist Medical Systems is recalling Kodama Intravascular Ultrasound Catheters because damaged o-ring fragments could be flushed out of the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (foreign material flushing) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Acist Medical Systems is recalling 1,185 units of the Kodama Intravascular Ultrasound Catheter, a component of the ACIST HDi System used for ultrasound examination of coronary and peripheral intravascular pathology. The recall was initiated after manufacturing line testing identified a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that fragments of the damaged o-ring larger than 200 microns had the potential to be flushed out of the catheter.
The affected units were distributed worldwide, including in the United States and in India, Italy, Japan, Poland, and the United Arab Emirates. Specific model numbers and lot codes are listed in the official recall documentation. Acist Medical Systems is currently confirming the source of the failure mode to ensure the quality and reliability of the catheter.
There have been no related field reports, nor any evidence or report of patient injury or adverse health consequence associated with this incident. Healthcare providers and patients should contact Acist Medical Systems for further instructions regarding the return or replacement of these devices.
The recalled product
- 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 ultraso
- Manufacturer
- Acist Medical Systems
- Affected units
- 1,185
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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)
Distribution
Related recalls
Same manufacturer · Acist Medical Systems
See all →- HighAcist Medical Systems Recalls BT2000 and CPT2000 Automated Manifold Kits
FDA (Devices) · 2016-02-10
- HighACIST Angiographic Injection System Recall for Air Ingress
FDA (Devices) · 2013-04-24
Same hazard · foreign object
See all →- SevereOutshine Strawberry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Black Cherry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Grape Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Watermelon Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02