We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Cardiac perforations associated with Medtronic’s Micra leadless pacemakers are more likely to be associated with “serious complications, such as cardiac tamponade or death,” the FDA said. Read More
An FDA inspection of a Philips Respironics facility in Pennsylvania has turned up problems that will delay the company’s replacement of millions of its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. Read More
The reason for the recall of certain lots of Ellume’s COVID-19 Home Tests, totaling more than 2.2 million individual tests in all, is that they have a higher-than-acceptable rate of false-positive test results. Read More
There have been 42 reports of plunger retraction and introduction of air into the Cardinal Health syringes, which are included in Windstone’s custom convenience kits, but no reports of complaints, injuries or deaths. Read More
There have been three complaints, but no deaths or injuries reported due to the software error with Zimmer Biomet’s Rosa One 3.1 Brain Application, the FDA says. Read More
Medtronic has issued a warning to healthcare providers that its Model B35200 Percept PC implantable neurostimulator might fail following a cardioversion procedure for treatment of cardiac arrhythmia. Read More
Use of the needles could result in inflammatory reactions, including systemic reactions that may lead to permanent impairment or death, the agency said. Read More
RSS
