Class 1 Device Recall WIRION EMBOLIC PROTECTION SYSTEM

• Date Initiated by Firm: November 22, 2021
• Date Posted: December 21, 2021
• Recall Status: Terminated on August 31, 2023
• Recall Number: Z-0394-2022
• Recall Event ID: 89120
• 510(K)Number: K210282
• Product Classification: Temporary Carotid Catheter for Embolic Capture - Product Code NTE
• Product: WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
• Code Information: Lot Numbers: Lot 67876, UDI 011085000049188217221221100000067876 Lot 70309, UDI 011085000049188217230110100000070309 Lot 68706, UDI 011085000049188217221227100000068706 Lot 69543, UDI 011085000049188217230103100000069543 Lot 75758, UDI 011085000049188217230203100000075758 Lot 77278, UDI 011085000049188217230210100000077278 Lot 79994, UDI 011085000049188217230223100000079994 Lot 81252, UDI 011085000049188217230301100000081252 Lot 81986, UDI 011085000049188217230307100000081986 Lot 83080, UDI 011085000049188217230313100000083080 Lot 81998, UDI 011085000049188217230320100000081998 Lot 84796, UDI 011085000049188217230327100000084796 Lot 87909, UDI 011085000049188217230411100000087909 Lot 89035, UDI 011085000049188217230418100000089035 Lot 86622, UDI 011085000049188217230404100000086622 Lot 90096, UDI 011085000049188217230424100000090096 Lot 93949, UDI 011085000049188217230515100000093949 Lot 91603, UDI 011085000049188217230501100000091603 Lot 94895, UDI 011085000049188217230521100000094895 Lot 91939, UDI 011085000049188217230507100000091939 Lot 101930, UDI 011085000049188217230717100000101930
• Recalling Firm/ Manufacturer: Cardiovascular Systems Inc; 1225 Old Highway 8 NW; Saint Paul MN 55112-6416
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: Consignees were issued an URGENT: Medical Device Recall letter dated 11/22/2021. Consignees are asked to immediately remove from use and return affected devices to CSI. To do so: 1) Complete the attached Customer Acknowledgement Form. a) Per lot, document the quantity of all devices that are to be returned. b) Per lot, document the quantity of all devices that have been consumed. 2) Place the Acknowledgement Form with the device. 3) Return the device and Acknowledgement Form to CSI using the pre-paid label. A CSI Sales representative can return the device and form. Please contact CSI Recall Coordinator to organize pick up and return of the product. If all products specified in this recall notice have previously been consumed, used or are no longer available for return to CSI, please complete the Customer Acknowledgement Form per the above, and return the form to CSI in the provided envelope. For further info, please contact: Cardiovascular Systems, Inc. Field Action Hotline csifieldactionhotline@csi360.com 651-259-2800
• Quantity in Commerce: 711 units
• Distribution: United States- AK, AL, AR, AZ, CA, DC, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS - Netherlands
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NTE and Original Applicant = Cardiovascular Systems Inc.