The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices can cause serious injury or death.
Product Name: Dragonfly OpStar Imaging Catheter:
Product lot numbers: see recall database entry
Devices recalled in the US: 4,800
Date started by company: April 11, 2022Read:TMC plans to build massive biomanufacturing, distribution center
The Dragonfly OpStar Imaging Catheter with Optical Coherence Tomography (OCT) Imaging System is designed to provide imaging of blood vessels that carry blood and oxygen to the heart (coronary arteries) in individuals candidates for catheter-based, minimally invasive, interventional procedures to diagnose coronary arteries. tackle heart disease.
Reason for recall
Abbott is recalling certain batches of the Dragonfly OpStar Imaging Catheter because the marker band furthest from the catheter tip (proximal marker) can become detached and has been observed in two cases to detach from the catheter while being used on a subject.
A loose marker band that has detached from the device may remain in the body after the catheter is removed, potentially leading to vascular injury, including but not limited to embolism (obstruction of the vessel), thrombosis (blood clot), dissection (tear) ischemia (insufficient blood supply to the heart), infarction (heart attack), infection or death.
There have been 5 incidents and 1 injury related to this device issue. Due to this issue, no deaths have been associated with the use of this device.
Who can be affected?
- Healthcare personnel using the Dragonfly OpStar Imaging Catheter for OCT imaging of the coronary arteries.
- People who will undergo catheter-based OCT imaging of the coronary arteries using the Dragonfly OpStar Imaging Catheter. This issue does not affect people who have already undergone this procedure.
What must we do
On April 11, 2022, Abbott sent an urgent medical device recall letter to all customers who received affected devices. The following instructions were included:Read:Khan Porter on Mental Strength & Dealing With Defeat
- Immediately stop using devices from affected lots
- Review the inventory and complete the effectiveness check form that accompanies the emergency medical device recall letter.
- Return all unused affected devices to Abbott.
- Please share this information with all relevant personnel.
- Notify anyone who may have received these affected products through additional distribution or transfer.
- Report product performance issues or adverse events to Abbott.
Customers with questions or concerns about this recall should contact their local Abbott representative or call Customer Service at 800-227-9902.
How do I report a problem?
Healthcare professionals and consumers can report side effects or quality problems they have experienced with the use of these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or FAX.