2012

Devices that are used to measure vital statistics in order to allow doctors to make an accurate diagnosis have been recalled due to a risk that the results shown will be incorrect. The items in question are called Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays.  These products, which were distributed by Roche Diagnostics… read more

The U.S. Food and Drug Administration has issued a report announcing their recommendation that transvaginal mesh devices be re-classified as a high risk medical device, according to news sources. The FDA is requiring new safety statistics be submitted by the manufacturer in order for the product to remain on the market. A panel will meet… read more

The Food and Drug Administration is warning patients against using Medtronic pumps because they may fail to deliver drugs, according to news sources. The specific drug pumps are used to administer drugs to treat chronic pains and spasms, among other conditions. The defective issue is caused by a film that forms over the battery. The… read more

A new study points to batteries as the leading problem when it comes to automated external defibrillator (AED) failures, according to news sources. The study, published in the Annals of Emergency Medicine, reported that in the last 15 years, AED failures have been linked to 1,150 deaths. Of these, 1 in 4 were battery related… read more

News sources report, that Medtronic Inc. issued a class 1 recall Monday of its SynchroMed II implantable drug infusion pump, making this the second such recall of the product this year. The recalled pumps have an issue with the battery that can lead to sudden failure of the device. Class 1 recalls are reserved for… read more

The U.S. Food and Drug Administration announced in a news release Friday that Vital Signs Devices, a GE Healthcare Company, has initiated what the company is calling a “voluntary worldwide field correction” of a medical humidifier due to a defect that may cause insufficient oxygen to reach a patient. The field correction, which the FDA… read more

News sources say that, according to the FDA, in 2010, doctors performed more than 100,000 prolapse repairs using surgical mesh, and about 75 percent of them were transvaginal. Between 2005 and 2007, the agency received more than 1,000 reports of adverse events related to the mesh in women diagnosed with pelvic organ prolapse or stress… read more

Janet Holt told media sources that she believed she just had some sort of infection “down there.” But her doctor told her that she was in need of an operation, explaining that her bladder had slipped out of place and created an uncomfortable condition called pelvic organ prolapse, which is common among women as they… read more