Dragonfly Opstar Imaging Catheter
Brand(s)
Last updated
Summary
Product
Dragonfly Opstar Imaging Catheter
Issue
Medical devices - Quality issue
What to do
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Abbott Medical
4 Robbins Road, Westford, Massachusetts
United States, 01886
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-64111
Get notified
Receive notifications for new and updated recalls and alerts by category.