Abbott Recalls Dragonfly OpStar Imaging Catheter for Loose Marker Band That May Cause Patient Harm

U.S. Food and Drug Administration sent this bulletin at 05/26/2022 11:14 AM EDT

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CDRH Medical Device Recall

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Abbott Medical Recalls DragonFly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm

Abbott is recalling certain lots of the Dragonfly OpStar imaging catheter with optical coherence tomography (OCT) imaging system because the marker band farthest from the catheter tip (proximal marker) may become loose and/or separate from the catheter. A loose marker band could separate from the device and remain in the body after the catheter is removed, potentially leading to blood vessel (vascular) damage and/or other patient harm.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

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Questions?

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