FDA MedWatch - WIRION Embolic Protection Device by Cardiovascular Systems

Class I Recall - Due to Complaints of Filter Breakage During Retrieval

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: WIRION Embolic Protection Device by Cardiovascular Systems: Class I Recall - Due to Complaints of Filter Breakage During Retrieval AUDIENCE: Health Professional, Patient, Risk Manager, Cardiology   ISSUE: Cardiovascular Systems Inc. is recalling the WIRION system due to complaints of filter breakage during retrieval. Under certain circumstances, such as when the filter basket is too full, the filter assembly may become difficult to withdraw. 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. Cardiovascular Systems Inc. has received reports of nine device malfunctions and no reports of death related to this device issue. For more information about this recall, click on the red button "Read Recall below. BACKGROUND: The WIRION system is used to hold and remove debris or blood clots from the lower limbs that can be associated with  atherectomy procedures. RECOMMENDATION: On November 22, 2021, Cardiovascular Systems Inc. sent an urgent notification recall letter to customers instructing them: Remove the device from distribution and return the device to Cardiovascular Systems Inc. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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