Acist Medical Systems recalls Kodama Intravascular Ultrasound Catheters with damaged o-rings that could flush out of the catheter during use. No injuries reported.
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.
Acist Medical Systems is recalling Kodama Intravascular Ultrasound Catheters due to a damaged o-ring that could flush out of the catheter during use. This poses a risk of potential blockage or injury during medical procedures, though no injuries have been reported.
Damaged o-rings in the catheter can break into pieces larger than 200 microns, which may flush out during use. This could potentially block blood vessels or cause injury during medical procedures, though no injuries have been reported.
Medical professionals using the ACIST HDi System for ultrasound examinations of blood vessels. Patients undergoing procedures with this catheter are at minimal risk since no injuries have been reported.
Check for model numbers 017788 or 018125 (Japan only) or lot codes listed in the recall notice. The catheter is part of the ACIST HDi System used for ultrasound imaging of blood vessels.
Review the model number and lot codes listed in the recall notice to confirm if your catheter is affected.
The recall states no injuries have been reported, but damaged o-rings could flush out during use. Medical professionals should check if their catheter is affected before use.
Model numbers 017788 and 018125 (Japan only) are affected, along with specific lot codes listed in the recall notice.
No injuries or adverse health consequences have been reported related to this issue.
We’ve drafted a message you can send Acist Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1161-2021 — Acist Medical Systems Acist Medical Systems Hello, I own a Acist Medical Systems that is covered by recall Z-1161-2021 from Acist Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
