WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (...
FDA Device Recall #Z-0394-2022 — Class I — November 22, 2021
Recall Summary
| Recall Number | Z-0394-2022 |
| Classification | Class I — Serious risk |
| Date Initiated | November 22, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cardiovascular Systems Inc |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 711 units |
Product Description
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
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.
Distribution Pattern
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
Lot / 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
Other Recalls from Cardiovascular Systems Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2385-2021 | Class II | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHEREC... | Jul 21, 2021 |
| Z-2386-2021 | Class II | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY... | Jul 21, 2021 |
| Z-3021-2018 | Class II | CSI, Orbital Atherectomy System (OAS) Saline In... | Apr 13, 2018 |
| Z-0506-2018 | Class II | Peripheral Diamondback 1.50 Solid OAD, a percut... | Sep 14, 2017 |
| Z-0505-2018 | Class II | Peripheral Diamondback 1.25 Solid OAD, a percut... | Sep 14, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.