A weight-loss procedure involving inserting a silicone balloon into the stomach has been associated with five deaths within the past year.
According to the FDA, Orbera Intragastric Balloon System and ReShape Integrated Dual Balloon System were linked to the five deaths. Continue reading “FDA Issues Safety Alert on Balloon Surgery for Obesity Treatment”
Doctors, hospitals, and patients alike are concerned about the recent recall of a line of coronary catheters. Three of Abbott Vascular’s products have a record of malfunction that has proven fatal in one case. Accordingly, Abbott voluntarily recalled these devices on March 22, 2017. Could this recall have affected you? Continue reading “FDA Announces Recall on Abbott Vascular Coronary Catheters”
Ultherapy is marketed as a “non-invasive face lift” with “no downtime” and “natural results” that uses ultrasound technology to improve the appearance of lines and wrinkles on the face, neck, and chest. Unfortunately, many Ultherapy patients are reporting “botched” procedures resulting in permanent side effects and worsened appearance. Cases of severe nerve damage, eye damage, and disfigurement have been reported following the treatment. Continue reading “Ultherapy Face and Nerve Damage”
More than one dozen lawsuits have been filed against Bair in connection with the Bair Hugger warming blanket used during surgical procedures. Claims state that the device is defective. The warming blanket can come in contact with bacteria and contaminants on operating room floors, which can get into the procedure location causing infections and other serious illnesses. Continue reading “3M Bair Hugger Warning: Infections Associated with Orthopedic Surgery”
The Food and Drug Administration (FDA) has issued a Class I Recall of all Brainlab Cranial Image-Guided Surgery Systems before version 3.0. This comes after findings exposed errors in the navigation system that can lead to serious injury and/or death. Continue reading “FDA Class I Recall: Brainlab Cranial Image-Guided Surgery System”
Two deaths have been reported as a result of potential superbug contamination in endoscopes used at the University Of California Los Angeles Medical Center. Endoscopes are inserted through the throat to examine the body from the inside. A small camera is on the end of medical-grade flexible tubing. Endoscopes are reusable medical devices, requiring a thorough cleaning process following each use. Continue reading “Superbug-Contaminated Endoscope Lawsuit – 2 Deaths Reported”
Covidien Components of Defibrillators May Cause Organ Failure, Strokes or Death
The FDA has issued a Class 1 safety alert for the electrodes used in defibrillator medical devices listed below. A Class 1 alert is the most serious issued by the FDA.
The concern is that devices using Covidien electrodes may delay or fail to activate the electrical shock used to restart the heartbeat of patients during heart attacks, leading to strokes, organ failure or death. Reports of the delay when trying to restart the hearts of two patients resulted in one death. Continue reading “Covidien Defibrillation Electrodes: FDA Class 1 Safety Alert”
The U.S. Supreme Court refuses an appeal from medical device manufacturer Medtronic in a liability lawsuit filed by an Arizona man allegedly left paralyzed by a Medtronic pain pump.
In a related Medtronic matter, Attorney Matt Harman discusses a lawsuit filed on behalf of a mother claiming her daughter died due to a defect and malfunction of her Medtronic insulin pump, prior to the manufacturer providing the FDA with information that later led to a Class 1 recall: Continue reading “VIDEO: Medtronic Pump Lawsuit Advances, U.S. Supreme Court Denies Mfr. Appeal”
Concerns prompt FDA to issue additional safety alert
The FDA issued a “Safety Communication” May 6, 2014 regarding the potential for harm to patients from a small, cage-like medical device implanted in blood veins. The device, the Interior Vena Cava (IVC) filter, is used in patients at risk of developing blood clots or embolisms anywhere in the body, but especially in their legs (which is called deep vein thrombosis). The filter device is an option for patients who cannot take blood thinners. Blood clots and embolisms can travel to heart, lungs, and other organs, causing serious damage or death. Continue reading “FDA: Blood Vein Filters (IVC’s) Could Cause Life Threatening Damage or Death”
Followup to December 2013 Class 1 recall of the HeartWare, Inc. Heartware Ventricular Assist System
In December of last year, the FDA issued its most serious recall, Class 1, for the HeartWare, Inc. “Heartware Ventricular Assist System” pump mechanism. The manufacturer followed up yesterday by reissuing a warning to physicians following additional reports of device failure. Continue reading “Heartware Ventricular Assist System Pump Connector Failure Could Lead to Death: Manufacturer Reissues Warning Following FDA Class 1 Recall Issued”