FDA announces recall of Abbott imaging catheter


FDA announces recall of Abbott imaging catheter
May 26, 2022

Abbott has recalled certain lots of its Dragonfly OpStar imaging catheter because a marker band may separate from the catheter and remain in the patient after use, potentially causing injury, the Food and Drug Administration announced today. The catheter is used for optical coherence tomography of coronary arteries. Five related incidents and one injury have been reported. Health care providers should immediately stop using devices in the affected lots and report any product performance issues to Abbott, FDA said.

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