WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6

FDA device recall Z-0394-2022 · posted 2021-12-21 · Terminated

Recall details

Recalling firm

Cardiovascular Systems Inc

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.

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

NTE

Quantity affected

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

Date initiated

2021-11-22

Date posted

2021-12-21

Date terminated

2023-08-31

Location

Saint Paul, MN

Related 510(k) clearances