Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
WIRION EMBOLIC PROTECTION SYSTEM Recalled by Cardiovascular Systems Inc Due to Under certain circumstances, the WIRION filter assembly may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cardiovascular Systems Inc directly.
Affected Products
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Quantity: 711 units
Why Was This Recalled?
Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.
Where Was This Sold?
This product was distributed to 37 states: AL, AK, AZ, AR, CA, FL, GA, HI, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, ND, OH, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC
About Cardiovascular Systems Inc
Cardiovascular Systems Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report