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”→
Trilogy Ventilator power management boards have been recalled due to a failure in the system that could interrupt or stop the mechanical breathing in the continuous or intermittent ventilator support for patients.
The FDA has republished a Class 1 recall, the most serious, for the Hospira Inc. GemStar Infusion System.
The GemStar pump by Hospira is designed to deliver fluids via IV, to lower back or spinal areas, and in other parts of the body. It is small, lightweight and can be portable when using battery power. Designed for use in the hospital, home, or other settings, the electronic infusion system can deliver medications, nutrition, and blood or blood products. Continue reading “Class 1 Recall: Hospira Inc., GemStar Infusion System”→
The FDA has classified the Medtronic cardiac “guidewires” recall as a Class 1, the most serious category.
Medtronic issued a voluntary recall of the “guidewires,” the wire connectors used to connect cardiac devices that help regulate heartbeat and other functions and facilitate heart surgery because the coating on the wire may disintegrate causing the wire to detach and put the patient at risk for injury or death. Continue reading “Recall of Medtronic Cardiac “Guidewires””→
The Harman Law Firm has filed a complaint against the manufacturer of the Medtronic MiniMed Paradigm MMT 722 Insulin Pump following the death of a young woman who was using the device
The MiniMed Insulin Pump is designed to deliver insulin continuously into the body, making multiple injections per day unnecessary. The young college student with the MiniMed pump died from “diabetic ketoacidosis,” a condition that results from uncontrolled blood sugar that can quickly lead to heart failure, kidney failure, coma or death. Continue reading “Medtronic MiniMed Paradigm Insulin Pump: Lawsuit Filed”→
The FDA issued a Class 1 recall March 29, 2013 for dialysis treatment concentrates Granuflo and NaturaLyte after 941 patients in 2010 suffered heart attacks while being treated with the substances. Fresenius Medical Care North America is being investigated for failing to warn the over 130,000 dialysis patients they treat each year of the risks. Continue reading “Dialysis Related Injury and Death: Granuflo and NaturaLyte Recall”→
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