Use caution Medical device recall · FDA · Published November 22, 2021

Cardiovascular Systems WIRION Embolic Protection System Recall: Risk of Device Tearing

Cardiovascular Systems recalls WIRION Embolic Protection System (model WRN-D6) due to risk of device tearing during use, which could cause embolization. Affected units have specific lot numbers and UDI codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0394-2022Medical device Cardiovascular Systems ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmCardiovascular Systems Inc1225 Old Highway 8 NW · Saint Paul, MN 55112-6416

✎ GovInfoNow plain-language explainer

Cardiovascular Systems is recalling its WIRION Embolic Protection System (model WRN-D6) because the filter assembly can become difficult to withdraw under certain conditions. This risk may lead to the device tearing or separating, potentially causing embolization if not handled properly. Read more at govinfonow.com/recall/61511-cardiovascular-systems-wirion-embolic-protection-system-recall-risk-of-device.

Source Summary by GovInfoNow · govinfonow.com/recall/61511-cardiovascular-systems-wirion-embolic-protection-system-recall-risk-of-device · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0394-2022

Cite this page

“Cardiovascular Systems WIRION Embolic Protection System Recall: Risk of Device Tearing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61511-cardiovascular-systems-wirion-embolic-protection-system-recall-risk-of-device. Based on FDA recall #Z-0394-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0394-2022%22&limit=1).

The FDA announced on November 22, 2021, that Cardiovascular Systems Inc. is recalling the WIRION EMBOLIC PROTECTION SYSTEM due to a risk of embolization if the filter assembly tears or separates. The agency said the device may become difficult to withdraw under certain circumstances.

How to tell if you have it

Brand: Cardiovascular Systems
Product: WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr
Model Number: WRN-D6
Lot Numbers: 67876, 70309, 68706, 69543, 75758, 77278, 79994, 81252, 81986, 83080, 81998, 84796, 87909, 89035, 86622, 90096, 93949, 91603, 94895, 91939, 101930
Units affected: 711

The hazard

According to the FDA, under certain circumstances, the WIRION filter assembly may become difficult to withdraw. The device may be prone to tearing or separating which may result in a risk for embolization.

Context

GovInfoNow's records show Cardiovascular Systems Inc. has 3 other recalls on record since September 14, 2017. Other recent recalls of similar products include DIAMONDBACK 360 GEN2 Orbital Atherectomy System Recall (July 21, 2021) and CSI Orbital Atherectomy Saline Pump Recall (April 13, 2018). Other recent recalls of similar products include Boston Scientific FARADRIVE Steerable Sheath Clear IDE Recall (June 11, 2026), Boston Scientific FARADRIVE Steerable Sheath Recall (June 11, 2026), and Boston Scientific FARADRIVE Steerable Sheath Recall (June 11, 2026).

How to tell if you have this one

Check for the model number WRN-D6 on the device. Affected units have specific lot numbers (67876 through 101930) and unique device identifiers (UDIs) listed in the recall notice.

Brand
Cardiovascular Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Review the lot number and unique device identifier (UDI) on the device to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 36 states and D.C., and outside the U.S.

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Nov 22, 2021Firm started the recall
Dec 21, 2021FDA classified it Class I
Dec 29, 2021Published in FDA’s Enforcement Report
Aug 31, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61511-cardiovascular-systems-wirion-embolic-protection-system-recall-risk-of-device">Cardiovascular Systems WIRION Embolic Protection System Recall: Risk of Device Tearing (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0394-2022 (November 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0394-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.