Dragonfly Opstar Imaging Catheter
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or Serial Number |
Model or catalog number |
|---|---|---|
Dragonfly Opstar Imaging Catheter |
8257087, 8220675, 8257085, 8220673, 8274128 |
1014651 |
Issue
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
Additional information
Details
Abbott Medical
4 Robbins Road, Westford, Massachusetts
United States, 01886
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