Recall Z-0394-2022 ยท NTE Temporary Carotid Catheter For Embolic Capture
Cardiovascular Systems Inc
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
| Date | Dec 21, 2021 (initiated Nov 22, 2021) |
| Status | Terminated |
| Reason | 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. |
| Root 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 Reca |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210282 | WIRION Embolic Protection System Cardiovascular Systems, Inc., Mar 3, 2021 |