Medical Device Safety
The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors by Abbott Diabetes Care due to incorrect glucose readings that are lower than actual blood glucose levels.
The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products.
The Food and Drug Administration has identified a recall by Cook Medical of Zenith Alpha 2 Thoracic Endovascular Graft proximal components after Cook Medical found that scrapings of polytetrafluoroethylene coating may be released inside the stent graft during use. Impacted components include all…
How hospitals expand infection prevention and surveillance to reduce bloodstream infections and improve patient safety. - TrailBlazers
The Food and Drug Administration has identified a Class I recall of Abiomed Automated Impella Controllers due to the potential for serious injury or death.
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.…
Health care leaders may want to keep a closer eye on clinical validation for artificial intelligence (AI)-enabled medical devices (AIMDs), based on a recent JAMA Health Forum study.
The Food and Drug Administration has identified Class I recalls for the following products due to the potential for serious injury or death:
The Food and Drug Administration has identified a Class I recall of certain lots of Medline Industries Craniotomy Kits containing recalled Codman Disposable Perforators 14mm due to the potential of serious injury or death.
The Food and Drug Administration issued Class I recalls, the most serious type, for two Smiths Medical infusion pumps due to the potential for serious injury or death.