FDA announces recall of Abbott imaging catheter
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.
Related News Articles
Headline
The Food and Drug Administration Feb. 23 withdrew approval of Pepaxto (melphalan flufenamide), a drug once used with dexamethasone to treat certain U.S.…
Headline
AHA today submitted comments on how the Agency for Healthcare Research and Quality can best support the field in advancing patient safety through an…
Headline
AHA today urged the Federal Trade Commission to scrutinize commercial health plans that steer patients to third-party specialty pharmacies in which they have a…
Headline
The Food and Drug Administration last week extended to 24 months the shelf life for certain lots of refrigerated bamlanivimab. The combination monoclonal…
Headline
Medtronic this week alerted health care providers to a defect in its Heartware Ventricular Assist Device System that may cause the internal pump to malfunction…
Headline
April 30 is National Prescription Drug Take Back Day, an opportunity for the public to safely dispose of unwanted or expired tablets, capsules, patches and…