News | Cath Lab | May 26, 2022

Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band

The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has identified this as a Class I recall, the most serious type of recall.

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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 people who are candidates for catheter-based, minimally invasive, interventional procedures to address coronary artery disease.

Reason for Recall

Abbott is recalling certain lots of the Dragonfly OpStar imaging catheter because the marker band farthest from the catheter tip (proximal marker) may become loose and, in two instances, has been observed to separate from the catheter while being used on a person.

A loose marker band that has separated from the device may remain in the body after the catheter is removed, potentially leading to vascular injuries, including but not limited to embolism (blockage of the vessel), thrombosis (blood clot), dissection (tear), ischemia (inadequate blood supply to the heart), infarction (heart attack), infection, or death.

There have been 5 incidents and 1 injury related to this device issue. No deaths have been associated with the use of this device due to this issue.

Who May be Affected

  • Health care personnel who use the Dragonfly OpStar Imaging Catheter for OCT imaging of the coronary arteries.
  • People who will have catheter-based OCT imaging of the coronary arteries using the Dragonfly OpStar Imaging Catheter. This issue does not impact people who have already had this procedure.

Recalled Product

  • Product Name: Dragonfly OpStar Imaging Catheter

  • Product Lot Numbers: See recall database entry

  • Devices Recalled in the U.S.: 4,800

  • Date Initiated by Firm: April 11, 2022

What to Do

On April 11, 2022, Abbott issued an Urgent Medical Device Recall letter to all customers who received affected devices. The following instructions were included:

  • Immediately stop using devices from affected lots
  • Review inventory and complete the Effectiveness Check Form Included with the Urgent Medical Device recall letter.
  • Return all unused affected devices to Abbott.
  • Share this information with all relevant personnel.
  • Notify anyone who may have received these affected products through additional distribution or transfer.
  • Report any product performance issues or adverse events to Abbott.

Contact Information

Customers with questions or concerns about this recall should contact their local Abbott representative or call the customer service department at 800-227-9902.

Related Dragonfly OpStar Imaging Catheter information:

FDA Clears Abbott OCT Imaging Enhanced With Artificial Intelligence

Abbott’s New Artificial Intelligence OCT Coronary Imaging Platform Launches in Europe

Related Content

News | Cardiovascular Business

June 28, 2022 — – Atlas Healthcare Partners – which specializes in developing and managing ambulatory surgery centers ...

Home June 28, 2022
Home
News | Cardiovascular Business

June 22, 2022 — Dr. Thomas Forbes, an interventional cardiologist, has joined Joe DiMaggio Children’s Hospital as its ...

Home June 22, 2022
Home
News | Cardiovascular Business

June 7, 2022 — Michael Bowdish, MD, MS, a national leader in cardiac surgery and among a handful of cardiac surgeons ...

Home June 07, 2022
Home
Feature | Cardiovascular Business | By Melinda Taschetta-Millane

Here is what you and your colleagues found to be most interesting in the field of cardiology during the month of May ...

Home June 01, 2022
Home
News | Cardiovascular Business

May 25, 2022 — MedStar Heart & Vascular Institute announced that Thomas E. MacGillivray, MD, has been named physician ...

Home May 25, 2022
Home
News | Cardiovascular Business

May 16, 2022 — Boston Scientific announced that Peter M. “Pete” Nicholas, co-founder and former CEO of Boston Scientific ...

Home May 16, 2022
Home
News | Cardiovascular Business

May 12, 2022 — Abbott announced a new partnership with Women as One to launch a new program designed to train more ...

Home May 12, 2022
Home
News | Cardiovascular Business

May 12, 2022 — NDA Partners General Manager, Eric Fish, announced today that Peter Mackrell, MD, a board certified ...

Home May 12, 2022
Home
News | Cardiovascular Business

May 11, 2022 — Vital Heart & Vein, a leading provider of cardiovascular and vein health, has named Gay Nord as its new ...

Home May 11, 2022
Home
Feature | Cardiovascular Business

Here are the top 10 performing videos on the Diagnostic and Interventional Cardiology (DAIC) website during the month of ...

Home May 09, 2022
Home
Subscribe Now