• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Medical Tubing and Extrusion

Medical tubing and extrusion technologies

  • Technologies
    • Balloons
    • Brain-computer interfaces
    • Cardiac Implants
    • Catheters
    • Endoscopes
    • Heart valves
    • Pulsed Field Ablation
  • Components
    • Connectors
    • Needles and Injections
    • Seals
    • Tubing Components
  • Manufacturing
    • Coatings
    • Extrusions
    • Machining
    • Molding
      • Injection Molding
      • Insert molding
      • Mold Components
    • Tools
  • Materials
    • Advanced Materials
    • Metals
    • Nitinol
    • Plastics
    • Silicone
  • Business
    • Distribution Agreements
    • Legal News
    • Mergers & Acquisitions
    • Partnerships
    • Personnel Moves
  • Regulatory
    • 510(k)
    • CE Mark
    • FDA Breakthrough Designation
    • ISO Certification
    • Pre-Market Approval (PMA)
    • Recalls
  • Suppliers
  • About Us

FDA issues Class I recall of Acist Kodama intravascular ultrasound catheter

March 18, 2021 By Danielle Kirsh

acist HD IUVC recallThe FDA yesterday designated an Acist Medical Systems recall of Kodama intravascular ultrasound catheters as Class I, its most serious level.

The Kodama intravascular ultrasound catheter (HD-IVUS) is designed to view the inside structure of an artery and any devices therein using high-frequency sound waves. The device is inserted through an artery in the leg and guided to the area that requires imaging.

Acist is recalling the catheter because the O-ring housing tubing may squeeze and damage the O-ring. Pieces of the O-ring may break free and flush into a patient’s artery during use if damaged, which could result in serious patient harm including vessel blockage, heart attack, heart arrhythmia or stroke with associated chest pain or discomfort. There have been no reported complaints, injuries or deaths, according to the FDA warning letter.

Overall, there are 490 devices involved in the recall.

Lot numbers affected in the recall include 00233370, 00233371, 00233372, 00233373 and 00233385 with distribution dates of Nov. 10, 2020 to Jan. 14, 2021.

Acist recommends healthcare providers remove the affected lots from inventory and return them to Stericycle.

Filed Under: Catheters Tagged With: Acist, stericycle

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

Primary Sidebar

“mte
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest trends and developments in medical tubing and extrusion.
MDO ad

Sponsored Content

A new way to access scientific papers?

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Inv Logo

MASSDEVICE MEDICAL NETWORK

MassDevice
DeviceTalks
Medical Design & Outsourcing
MedTech 100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World
Drug Delivery Business News

Medical Tubing + Extrusion

Subscribe to our E-Newsletter
Advertise with us
About
Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS