UNITED STATES – The medical device manufacturer Maquet is recalling thousands of cardiac devices called intra-aortic balloon pumps (IABPs) due to battery issues that could be life-threatening to patients. The U.S. Food and Drug Administration announced the recall in May 2019 because of concerns that the devices could lose charge and … [Read more...]
Cardiac Devices Due to Battery Issues
FDA Releases Draft Guidance on Medical Device Recalls
FDA Releases Draft Guidance on Voluntary Medical Device Recalls, Raising Concerns About Inconsistencies Between the Guidance and Current Regulations UNITED STATES – According to an online article published by www.raps.org, the FDA has released a draft guidance regarding the process for initiating voluntary recalls of medical … [Read more...]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...]
Power Morcellators Allegedly Spread Cancerous Tissue
Power Morcellators Designed To Remove Tissue. Power morcellators were designed to facilitate the removal of tissue during laparoscopic procedures. The morcellator works by breaking tissue into smaller chunks for easier removal. Power morcellators has been used as a replacement for traditional surgery as the smaller incision puts … [Read more...]
Radiation Overexposure Medical Devices Side Effects May Result In Radiation Overdose Lawsuits
Radiation Overdose Injury Lawsuits. Have you been the victim of excess radiation from a CAT scan or other medical imaging? According to recent studies, Americans are exposed to more radiation as a result of procedures like CAT scans than people elsewhere. Patients have even been injured by a radiation overdose from a single CAT scan. … [Read more...]
FDA Investigation Finds Underreporting of Medical Device Problems
Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA), but an FDA investigation has revealed that many hospitals are likely underreporting these events. This reporting helps the FDA identify potentially defective medical devices and prevent additional … [Read more...]
