The FDA has announced that Cardiovascular Systems is recalling its Wirion embolic protection device due to issues with the filter breaking off during the retrieval process. The recall covers a total of 697 devices.
The Wirion device was designed to hold and remove blood clots or other debris from a patient’s lower limbs, typically during an atherectomy procedure.
“Under certain circumstances, such as when the filter basket is too full, the filter assembly may become difficult to withdraw,” according to the announcement. “In this situation, withdrawal may cause the WIRION system filter component to tear or separate, which may result in series adverse events such as embolization, need for additional medical procedures, or possibly death.”
This is a Class I recall, meaning the use of this device “may cause serious injuries or death.” Nine malfunctions have been reported at this time, but no deaths. Devices included in the recall were manufactured from January 2021 to August 2021. They were distributed to customers from March 2021 to November 2021.
Any customers still in possession of one of these devices is advised to return it to Cardiovascular Systems.
Read the full advisory on the FDA’s website.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.