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.
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.
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.
The WIRION filter assembly can become difficult to withdraw during certain procedures. If not properly managed, this may cause the device to tear or separate, leading to embolization where particles could block blood vessels.
Medical professionals using the WIRION Embolic Protection System for cardiovascular procedures are most at risk. Patients undergoing procedures with this device may be affected if the system is used on recalled units.
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.
Review the lot number and unique device identifier (UDI) on the device to confirm if it is affected.
The model number is WRN-D6.
Affected lot numbers range from 67876 to 101930.
Check the lot number and unique device identifier (UDI) on the device against the list provided in the recall notice.
We’ve drafted a message you can send Cardiovascular Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0394-2022 — Cardiovascular Systems Cardiovascular Systems Hello, I own a Cardiovascular Systems that is covered by recall Z-0394-2022 from Cardiovascular Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
