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Dragonfly opstar imaging catheter
Official notice
25 Apr 2022
Last checked
25 Apr 2022
An official Health Canada notice concerns Dragonfly opstar imaging catheter. The proximal marker on devices from these lots may separate from the device. A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery. To date Abbott has received 5 complaints related to this issue, one which resulted in an embolism which required an additional intervention to resolve with no immediate adverse consequences. Potential risks include embolism, cardiovascular injury and myocardial ischemia. Recall start date: Apr 11, 2022 Published 2022-04-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64111
Official notice
2022-04-25
The hazard
The hazard
The proximal marker on devices from these lots may separate from the device. A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery. To date Abbott has received 5 complaints related to this issue, one which resulted in an embolism which required an additional intervention to resolve with no immediate adverse consequences. Potential risks include embolism, cardiovascular injury and myocardial ischemia. Recall start date: Apr 11, 2022
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.
Recall Numbers
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Affected products
Product 1
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
Company & contacts
Company & contacts
Brand: Abbott Medical, Dragonfly Opstar Imaging Catheter.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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