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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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.…"
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…
- 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
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