Abbott Dragonfly OpStar Catheter Recall Issued Over Tip Separation Risks

The FDA has decided the tip separation risks warrant a Class I recall designation, meaning the problems could cause severe injuries and death.

Federal safety officials have announced a recall for Dragonfly OpStar imaging catheters, warning that the defective devices may cause blood vessel damage and the need for immediate surgical intervention.

The Abbott Dragonfly OpStar imaging catheter recall was announced by the U.S. Food and Drug Administration (FDA) on May 26, due to the risk that catheter tip may separate and become lodged in a patient’s blood vessels, obstructing blood flow and resulting in serious injury or death.

The recall follows reports of catheter tips breaking off or separating during surgical procedures, and the FDA has become aware of at least five incidents of the catheter tip loosening or separating, including at least one patient injury.

The recall involves approximately 4,800 Dragonfly OpStar Imaging Catheter with optical coherence tomography (OCT) imaging system with model number 1014651. For a full list of the recalled lot numbers impacted, please visit the recall notice in the FDA recall database.

The catheter systems used in the hospital of healthcare facility setting and are designed to provide imaging of blood vessels that carry blood and oxygen to the heart for patients who suffer from coronary artery disease.

According to the recall, Abbott warns a marker band farthest from the catheter tip may become loose and has been observed separating from the catheter while being used on a patient.

Abbott and federal officials indicate that, in the event of the tip loosening and separating, the remaining piece of the device may stay in the body after the catheter is removed, potentially leading to vascular injuries such as embolism (blockage of the vessel), thrombosis (blood clot), dissection (tear), ischemia (inadequate blood supply to the heart), infarction (heart attack), infection, or death.

The FDA has given the recall a Class I designation, meaning the agency believes the problem can cause serious injuries or death to patients.

Abbott first alerted customers in an Urgent Medical Device Recall letter on April 11, instructing all customers to immediately stop using the recalled catheter systems and to quarantine any remaining inventory. The letter instructed hospitals and healthcare facilities to return all unused devices to the manufacturer and to share the notification to all relevant personnel.

For questions or concerns regarding the recall, customers may contact their local Abbott representative or contact the customer service department at 800-227-9902 and refernce the recall number Z-1095-2022. Healthcare professionals are being instructed to report any adverse events or product performance issues to the FDA’s MedWatch Adverse Event Reporting Program.