Medtronic Catheter Recall Issued Following Cardiac Complication Risks
A Class I Medtronic Catheter recall has been mandated by the U.S. Food and Drug Administration following a series of disturbing complaints about the 6 French Sherpa NX Active Guide series of cardiac catheters. Explaining the Medtronic Catheter Recall The FDA released the class I Medtronic catheter recall on October 8th, 2019. The … [Read more...] about Medtronic Catheter Recall Issued Following Cardiac Complication Risks
FDA Acknowledges Medical Device Underreported Malfunctions
WASHINGTON, D.C. — The United States Food and Drug Administration acknowledged that problems with medical devices are underreported. This is a dangerous situation, which, according to some, the FDA is making worse. Kaiser Health News said that many reports, including those filed regarding the Sprint Fidelis defibrillator manufactured … [Read more...] about FDA Acknowledges Medical Device Underreported Malfunctions
Doctor Exposes an FDA Policy that Endangers Patients
WASHINGTON, D.C. — A renown physician notice he had an irregular heartbeat and in 2006, he had a Sprint Fidelis defibrillator made by Medtronic implanted into his chest. The device was designed to shock the heart back into its correct rhythm if it skipped a beat. However, the device did not work as advertised. Instead, the device … [Read more...] about Doctor Exposes an FDA Policy that Endangers Patients
FDA to End Alternate Summary Reporting Program
WASHINGTON D.C. — An article from CNN revealed that Medtronic’s Sprint Fidelis cardiac pacemaker and tens of thousands of other devices are exempt from public scrutiny because the FDA would permit medical device manufacturers to file summary reports of malfunctions rather than file full reports that would be made public by the … [Read more...] about FDA to End Alternate Summary Reporting Program
FDA Medical Implant Testing Process Fails Women
TX – According to the newscentermaine.com, the Food and Drug Administration (FDA) does not put medical devices through the same level of scrutiny and rigorous testing as it applies to drugs. This can be problematic for the 7 million people who undergo surgical procedures in order to implant some form of a medical device into their … [Read more...] about FDA Medical Implant Testing Process Fails Women
