The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product (Include the following information)
- Product Names: WIRION Embolic Protection Device
- Product Codes: See Recall Database Entry
- Model Numbers: All products and lots
- Manufacturing Dates: January 3, 2021 to August 16, 2021
- Distribution Dates: March 22, 2021 to November 15, 2021
- Devices Recalled in the U.S.: 697
- Date Initiated by Firm: November 22, 2021
The WIRION® system is used to hold and remove debris or blood clots from the lower limbs that can be associated with atherectomy procedures.
Reason for Recall
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.
Who May be Affected
Patients receiving atherectomy procedures where the WIRION system was used.
What to Do
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.
Customers in the U.S. with questions about this recall should contact Cardiovascular Systems Inc. by phone at 651-259-2800.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.