• 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

Cardiovascular Systems’ recall of its Wirion embolic protection device is Class I

January 11, 2022 By Danielle Kirsh

cardiovascular-systems-logo

The FDA determined that Cardiovascular Systems’ recall of some of its Wirion embolic protection devices is Class I, the most serious kind.

St. Paul, Minnesota–based Cardiovascular Systems is recalling all products and lots of its Wirion embolic protection device due to complaints of filter breakage during retrieval. It includes devices with manufacturing dates of Jan. 3, 2021, to Aug. 16, 2021, with distribution dates of Mar. 22, 2021 to Nov. 15, 2021. There have been 697 devices recalled in the U.S., and the company has received reports of nine device malfunctions.

There are no reports of deaths related to the device.

In some circumstances, such as when the filter basket is too full, the filter assembly could become difficult to withdraw. Withdrawal could cause the filter component to tear or separate, which can result in adverse events such as embolization, need for additional medical procedures or possibly death.

Cardiovascular Systems designed the Wirion embolic protection device to hold and remove debris or blood clots from the lower limbs that can be associated with atherectomy procedures.

The company issued a voluntary recall of the devices in November last year when it informed all affected healthcare facilities to discontinue use of the device immediately and to return all unused products.

Filed Under: Catheters Tagged With: Cardiovascular Systems

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