Changing ICD generator elevates risk factor for Sprint Fidelis lead failures
malfunctions and failures with the Sprint Fidelis Patients relying on an implantable cardiac defibrillator (ICD) are more likely to experience malfunctions and failures with the Sprint Fidelis leads connecting it to the heart if they change the device's generator. According to a report at TheHeart.org, new research from Emory … [Read more...]
Medical Device Makers Label Thousands of Patient Deaths as “Injuries” or “Malfunctions”
Medical Device Makers Label. Device makers are labeling thousands of patient deaths as "injuries" or "malfunctions". Furthermore, it appears that these actions are in accordance with U.S. Food and Drug Administration (FDA) guidelines. Specifically, an NBC News investigation found that miscarriages associated with Bayer's Essure … [Read more...]
FDA Announces Class 1 Recall Baxter Infusion Pumps
Class 1 Recall Baxter Infusion Pumps. The U.S. Food and Drug Administration (FDA) and Baxter Healthcare Corporation have notified healthcare professionals regarding the class 1 recall of all models of Colleague and Colleague CX volumetric infusion pumps. The electronic devices are subject to multiple malfunctions that can delay or … [Read more...]
Medical Firm’s Dangerous Secret
Medical Firm Failed To Report Malfunctions Of Medical Device. When a Guidant Corp. subsidiary pleaded guilty in June to 10 federal felonies, it acknowledged failing to report thousands of malfunctions of a medical device used to repair bulges in the body's main artery. Twelve of the unreported cases ended in deaths. But the … [Read more...]
