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Abbott imaging catheter recall flagged as Class I by FDA

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Abbott's Dragonfly OpStar Imaging Catheter
Abbott’s Dragonfly OpStar Imaging Catheter [Photo courtesy of Abbott]
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall.

That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11.

The recall affects 4,800 devices in the U.S. from certain lots. Abbott is asking health care providers to stop using the devices.

Abbott’s Dragonfly OpStar Imaging Catheter and its optical coherence tomography (OCT) imaging system are designed to provide imaging of blood vessels that carry blood and oxygen to the heart in patients who are candidates for minimally invasive catheter-based procedures for coronary artery disease.

Abbott warned health care providers that the catheter’s proximal marker band (the one farthest from the catheter tip) may become loose and separate while being used on a patient. This has been observed at least twice, the FDA said.

The FDA said yesterday that a loose marker band that separates from the device can remain in the body after the catheter is removed, which could lead to vascular injuries such as embolism, thrombosis, dissection, ischemia, infarction, infection or death.

About Jim Hammerand

Jim Hammerand is the managing editor of Medical Design & Outsourcing. He has more than 15 years of professional journalism experience spanning newspapers, magazines, websites and broadcast news. For nearly a decade, he reported and edited business news for American City Business Journals as a reporter and digital editor at the Minneapolis/St. Paul Business Journal and then managing editor of the Puget Sound Business Journal in Seattle. He holds a bachelor’s degree in journalism from the University of Minnesota. He is based near Seattle in Edmonds, Washington, where he and his family live. Connect with him on LinkedIn or by email at jimhammerand@wtwhmedia.com.