Baxter Issues Volara Recall; Respiratory Device May Cause Respiratory Distress
On June 1, 2022, Baxter International Inc. announced an Urgent Medical Device Correction for its Volara System (home care). This Volara recall was voluntary. Baxter inherited the Volara device when it acquired Hillrom for $12.5 billion. According to the U.S. Food and Drug Administration (FDA), Baxter voluntarily issued the Urgent … [Read more...]
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...]
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...]
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...]
