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Cardiovascular WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6 - safety alert
Official notice
29 Dec 2021
Last checked
29 Dec 2021
An official FDA notice concerns Cardiovascular WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6 - safety alert. An official FDA notice concerns WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6. The notice reports a serious safety risk. Follow the official notice for consumer instructions. Published 2021-12-29. Lots: 67876, 70309, 68706, 69543, 75758 and 16 more. Recall numbers: Z-0394-2022. Check the official notice for the complete list. Published 2021-12-29.
What to do now
The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.
Units affected
711
Recall number
Z-0394-2022
Official notice
2021-12-29
The hazard
The hazard
An official FDA notice concerns WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6. The notice reports a serious safety risk. Follow the official notice for consumer instructions. Published 2021-12-29. Lots: 67876, 70309, 68706, 69543, 75758 and 16 more. Recall numbers: Z-0394-2022. Check the official notice for the complete list.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Lots
Event Ids
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Units affected
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Affected area 2
Company & contacts
Company & contacts
Brand: Cardiovascular. Contact: Cardiovascular Systems Inc.
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Status
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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