WIRION EMBOLIC PROTECTION SYSTEM — Class I medical device recall Z-0394-2022
Terminated recall by Cardiovascular Systems Inc, reported 2021-12-29, distributed in AK, AL, AR, AZ, CA, DC, FL, GA…. Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumsta
| Recall number | Z-0394-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiovascular Systems Inc, Saint Paul, MN, United States |
| Recall initiated | 2021-11-22 |
| Classified | 2021-12-21 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2023-08-31 |
| Distributed | 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 |
| Countries outside the US | NL |
| Quantity | 711 units |
| Lot numbers | 101930, 67876, 68706, 69543, 70309, 75758, 77278, 79994, 81252, 81986, 81998, 83080, 84796, 86622, 87909, 89035, 90096, 91603, 91939, 93949, 94895 |
| Model numbers | WRN-D6 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0394-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.